Individual at risk

Donor / Recipient

Guidance at RECRUITMENT for adult volunteer donor and maternal donor (cord blood donation)

Unacceptable if current or recent history of alcohol use disorder.

Unacceptable if history of alcoholic liver disease or cardiomyopathy.

Registries may wish to set an upper limit of safe alcohol consumption based on local recommendations.

Guidance at CT/WORK-UP

Unacceptable if current or recent history of alcohol use disorder.

Unacceptable if history of alcoholic liver disease or cardiomyopathy.

Registries may wish to set an upper limit of safe alcohol consumption based on local recommendations.

At the CT stage, registries may wish to request liver function tests in donors with a history of current or past alcohol use disorder.

Justification/References

Alcoholics or those with a heavy alcohol intake may be less reliable donors and there is a risk of donor attrition or withdrawal at a late stage. In addition, there is a possible risk of donation in those with alcohol-related organ damage, such as cirrhosis or cardiomyopathy.

G-CSF has been documented to cause transient rises in liver function tests, so should be used with caution in those with a history of liver disease related to alcohol.

Condition

Any abnormal immune-mediated reaction to a drug or other external stimulus, such as rash, tongue-swelling, and difficulty breathing.

Individual at Risk

Donor / Recipient

Guidance at RECRUITMENT/CT/WORK-UP for adult volunteer donor (NA for maternal donor (cord blood donation))

Latex

UNACCEPTABLE if anaphylaxis (life-threatening) or widespread allergy (i.e. rash all over the skin) to latex.

ACCEPTABLE if mild localised contact allergy to latex (e.g. a rash on the hands from wearing latex gloves).

Anaesthetic

UNACCEPTABLE if life-threatening or other severe allergy to any anaesthetic agent. However, other adverse effects (such as nausea, vomiting, fatigue) may be acceptable.

Other allergy

ACCEPTABLE at the discretion of the assessing physician. Donors with multiple severe allergies, particularly with a history of anaphylaxis to more than one allergen should not donate.

ACCEPTABLE if currently undergoing desensitisation therapy.

Inform transplant centre AND collection centre of any allergy, including hayfever.

Justification for guidance

During donation donors are exposed to a number of potential allergens, including G-CSF, anaesthetic agents and latex. There is a possibility of transfer of allergy to the recipient.

References

Tulpule S, Shaw BE, Makoni P, Little AM, Madrigal JA, Goldman JM. Severe allergic reaction with anaphylaxis to G-CSF (lenograstim) in a healthy donor. Bone Marrow Transplant 2009; 44(2): 129-30.

Hallstrand TS, Sprenger JD, Agosti JM, Longton GM, Witherspoon RP, Henderson WR, Jr. Long-term acquisition of allergen-specific IgE and asthma following allogeneic bone marrow transplantation from allergic donors. Blood 2004; 104(10): 3086-90.

Individual at risk

Donor / Recipient

Recommendation at RECRUITMENT

Establish cause and degree of anaemia. May be acceptable if benign cause and haemoglobin level is acceptable. Registries and donor centres should establish a lower limit for the an acceptable haemoglobin level based on local reference ranges.

Iron deficiency is acceptable if haemoglobin is within the limit set by the registry/donor centre, and with appropriate follow-up treatment.

It is not recommended to accept donors with G6PD deficiency at recruitment, but due to high allele frequencies in many non-Caucasian populations, it is likely that many male donors will have asymptomatic and undiagnosed G6PD deficiency.

Unacceptable if cause of anaemia is unknown, or due to autoimmunity or malignancy.

Recommendation at CT/WORK-UP

Establish cause and degree of anaemia. May be acceptable if benign cause and haemoglobin level is acceptable. Registries and donor centres should establish a lower limit for the an acceptable haemoglobin level based on local reference ranges, and these levels should take into account whether the donation is a bone marrow or PBSC harvest.

Iron deficiency is acceptable if haemoglobin is within the limit set by the registry/donor centre.

Donors with mild or asymptomatic G6PD deficiency may be acceptable at CT/work-up stage at the discretion of the transplant centre.

Unacceptable if cause of anaemia is unknown, or due to autoimmunity or malignancy.

Justification

Anaemia most commonly reflects iron deficiency, may be easily remediable and is not necessarily a barrier to donation. However, other causes, such as inherited diseases or acquired bone marrow disorders may prohibit donation.

A lower threshold of Hb concentration should be set because of the risk of a fall in haemoglobin as a consequence of donation, particularly when donating by bone marrow harvest.

References

Mijovic A, Britten C, Regan F, Harrison J. Preoperative autologous blood donation for bone marrow harvests: are we wasting donors’ time and blood? Transfus. Med.16(1),57–62 (2006)

Parkkali T, Juvonen E, Volin L, Partanen J, Ruutu T. Collection of autologous blood for bone marrow donation: how useful is it? Bone Marrow Transplant.35(11),1035–1039 (2005).

Condition

An abnormality of cardiac electrical activity, most commonly diagnosed by electrocardiography.

Guidance at RECRUITMENT for adult volunteer donor and maternal donor (cord blood donation)

QUALIFIED, SEE BELOW

Guidance at CT/WORK-UP

QUALIFIED, SEE BELOW

Individual at Risk

Donor

Qualified Guidance

Where possible, particularly at CT-stage and work-up, advice from a cardiologist should be sought.

Acceptable

Benign atrial or ventricular ectopics (extrasystoles)

Sinus tachycardia/bradycardia acceptable, but inform anaesthetist at work-up if for bone marrow harvest.

Beta-blockers prescribed for benign ectopics or sinus tachycardia are acceptable.

Supraventricular tachycardias (SVT), including atrial fibrillation/flutter, may be acceptable if successfully treated with catheter ablation and off rate/rhythm-control medications (such as beta-blockers) for at least one year.

Right bundle branch block in the absence of any other abnormality

First degree heart may be acceptable at work-up at the discretion of the assessing physician.

Unacceptable

Uncorrected atrial fibrillation/flutter

Any history of ventricular tachycardia/fibrillation

Wolff-Parkinson-White/Lown-Ganong-Levine syndromes unacceptable unless treated with catheter ablation, and no ECG evidence of accessory pathways.

Second (Mobitz type 1, 2 or Wenkebach) or third degree heart block

All pacemakers and implantable cardiac defibrillators (ICD)

Left bundle branch block

Long-QT syndrome, Brugada syndrome or any other known cause of sudden cardiac death

References

Halter J, Kodera Y, Ispizua AU, Greinix HT, Schmitz N, Favre G et al. Severe events in donors after allogeneic hematopoietic stem cell donation. Haematologica 2009; 94(1): 94-101.

Komatsu F, Shikata M. Abnormal electrocardiographic findings in apheresis donors. Transfusion 1988; 28(4): 371-4.

Laspina SJ, Browne MA, McSweeney EN, Lawlor J, Whelan DM, Kinsella AL et al. QTc prolongation in apheresis platelet donors. Transfusion 2002; 42(7): 899-903.

Povsic TJ, Losordo DW, Story K, Junge CE, Schatz RA, Harrington RA et al. Incidence and clinical significance of cardiac biomarker elevation during stem cell mobilization, apheresis, and intramyocardial delivery: an analysis from ACT34-CMI. Am Heart J 2012; 164(5): 689-697 e3.

Yuan S, Ziman A, Smeltzer B, Lu Q, Goldfinger D. Moderate and severe adverse events associated with apheresis donations: incidences and risk factors. Transfusion 2010; 50(2): 478-86.

Notes

One member of the review committee the acceptability of donors with a history of supraventricular tachycardia treated with catheter ablation and off rate-control medication for one year.

Condition

A disease characterized by recurrent attacks of breathlessness and wheezing, which vary in severity and frequency from person to person. During an attack, the lining of the passages swell causing the airways to narrow and reducing the flow of air in and out of the lungs. The condition is usually reversible and may require continuous or intermittent use of (steroid) medication, depending on the severity of the condition.

Individual at risk

DONOR

Guidance at RECRUITMENT

ACCEPT if condition is controlled with (daily) inhalers or non-steroidal oral medication

DEFER if condition requires oral steroids

Guidance at CT/WORK-UP

PBSC

ACCEPT if condition is controlled with (daily) inhalers or non-steroidal oral medication. The first dose of G-CSF should be supervised by a healthcare professional due to the risk of exacerbation.

DEFER if condition is poorly controlled and/or requires oral steroids

BM

MAY BE ACCEPTBALE if condition is controlled with (daily) inhalers or non-steroidal oral medication. However, all cases should be discussed with an anaesthetist at the time of work-up.

DEFER if condition is severe and/or requires oral steroids

All donors

If a donor is unsuitable for bone marrow harvest, the requesting transplant centre must be informed that there will not be an option of rescue marrow harvest in the case of failed mobilization.

Justification for guidance

Mild asthma is acceptable (and also accepted by most blood banks). However, the condition must be reassessed and evaluated in case of a HR/CT or work up request. The risk for exacerbation is increased if the condition is severe.

References

http://www.who.int/mediacentre/factsheets/fs307/en/index.html

Liccardi G, Salzillo A, Sofia M, D'Amato M, D'Amato G. Bronchial asthma. Curr Opin Anaesthesiol 2012; 25(1): 30-7.

Notes

ICD code 493

Condition

Babesiosis

Individual at risk

Donor / Recipient

Guidance at RECRUITMENT

DEFER if ever diagnosed with or treated for disease

Guidance at CT/WORK-UP

Consider accepting donor if asymptomatic and infection is historic, at the discretion of the requesting transplant centre.

Justification for guidance

References

Transfusion-Associated Babesiosis with an Atypical Time Course after Non-Myeloablative Transplantation for Sickle Cell Disease. 2008 Ann Intern Med 148(10):794-795

Transfusion-Associated Babesiosis in the United States: A Description of Cases. 2011 Ann Intern Med 155(8):509-519

Introduction

Back complaints are common and need to be considered on a case-by-case basis at both recruitment and CT/work-up stages.

General guidance for adult volunteer donor (NA for maternal donor (cord blood donation))

In general, donors undergoing a bone marrow collection run the risk of exacerbating pre-existing mechanical back conditions due to the shearing forces applied to the lower back and pelvis during the procedure. However, many such donors may donate by PBSC.

Donors with non-mechanical inflammatory back conditions, particularly those associated with autoimmune disease, such as ankylosing spondylitis, should not donate by either route.

Individual guidance

Common subgroups of back complaints are given separate guidance below:

Condition

A benign tumor is a mass of cells (tumor) that lacks the ability to invade neighboring tissue or metastasize. These do not spread into, or invade, nearby tissues; however, they can sometimes be quite large. When removed, benign tumours usually do not grow back, whereas malignant tumors sometimes do.

Guidance at RECRUITMENT

Accept if no severe uncontrolled symptoms.

Guidance at CT/WORK-UP

Accept if no severe uncontrolled symptoms and no surgery recently or in the near future.

Individual at Risk

None

Justification for guidance

There is no link between donation and benign tumours.

References

Donor suitability working group WMDA meeting Munich 2018

Condition

Bipolar affective disorder. Also known as manic depression.

Individual at Risk

Donor / recipient

Guidance at RECRUITMENT for adult volunteer donor and maternal donor (cord blood donation)

MAY BE ACCEPTABLE if not currently manic, or if condition adequately treated with medication or counselling. The condition should have been stable for at least one year.

In addition, if donor is taking neuroleptics, valproate or carbemazepine, it should be established that medication is well tolerated, with no significant effect on blood counts and liver function. Ask the following questions:

Can the donor work and travel?

Could the donor cope with a hospital stay if required to donate?

Could the donor cope with pressures involved with donating, as donation may be a stressful procedure for some individuals?

If the answer to these questions are yes, than accept.

Donors taking lithium

Donors taking lithium may donate by BM only.

Guidance at CT/WORK-UP

MAY BE ACCEPTABLE if not currently manic, or if condition adequately treated with medication or counselling. The condition should have been stable for at least one year.

In addition, if donor is taking neuroleptics, valproate or carbemazepine, it should be established that medication is well tolerated, with no significant effect on blood counts and liver function. Ask the following questions:

Can the donor work and travel?

Could the donor cope with a hospital stay if required to donate?

Could the donor cope with pressures involved with donating, as donation may be a stressful procedure for some individuals?

If the answer to these questions are yes, than accept.

Donors taking lithium

Donors taking lithium may be able to donate by BM only.

Justification for guidance

The majority of donors with bipolar affective disorder will be able to donate. There is anecdotal evidence of donors with mental illness withdrawing from donation at the last minute, but this behaviour has also been seen in non-depressed donors and forms no basis for deferral.

There is some evidence than those who are in a manic phase may have an impaired capacity to undergo informed consent, and as such these donors should be deferred until the mania has resolved.

Lithium may enhance the effect of G-CSF, thus its use is a protocol exclusion for PBSC.

References

Misra S, Ganzini L. Capacity to consent to research among patients with bipolar disorder. J Affect Disord 2004; 80(2-3): 115-23.

Focosi, D., Azzara, A., Kast, R. E., Carulli, G. & Petrini, M. 2009. Lithium and hematology: established and proposed uses. J Leukoc Biol, 85, 20-8.

Bleeding disorders not transmissible via HCST

Clotting factors synthesized by liver or endothelia; nutritional / by medication; vascular disorders:

Including:

Haemophilia A and B including symptomatic female carriers, Haemophilia C, Hypofibrinogenemia, Factor XII deficiency, combined factor deficiencies, von Willebrand Disease (Type I, II and III);

Vitamin K deficiency, oral anticoagulant therapy (see also Thrombosis and Thrombophilia);

Hereditary haemorrhagic telangiectasia (Osler disease), Ehlers-Danlos syndrome;

Individual at risk

Donor

Guidance at RECRUITMENT for adult volunteer donor and maternal donor (cord blood donation)

Unacceptable if history of bleeding complication.

Otherwise clinical reasoning by a physician should be used. May be eligible for donation by PBSC only.

Guidance at CT/WORK-UP

Check coagulation status already at CT, and extended coagulation status at Work-up.

Clinical reasoning by physician should apply. Donor could be eligible, eligible for PBSC only, temporarily unavailable or permanently deleted accordingly.

Justification for guidance

Obvious risk for bleeding complication during / after marrow collection PBSC risk due to transient low platelet counts, anticoagulation agents and venepuncture.

Bleeding disorders transmissible via HSCT

Thrombocyte disorders, acquired / immunogenic bleeding disorders, infections coagulopathies

Including:

Platelet dysfunction and asthenia; von Willebrand disease (platelet type)

Thrombocytopenia, including ITP, TTP and HIT in medical history

Individual at risk

Donor / recipient

Guidance at RECRUITMENT

Defer if history of bleeding, thrombocytopenia or thrombosis.

With clinical reasoning by the assessing physician, the donor might be eligible to join.

Guidance at CT/WORK-UP

With clinical reasoning by the assessing physician, such a donor might be eligible to donate, eligible for PBSC or BM only, be made temporarily unavailable or permanently deferred.

Inform requesting transplant centre and proceed only if requested.

Check coagulation and status at CT, and consider extended coagulation test at work-up if indicated.

Justification for guidance

Obvious risk for bleeding complication during / after BM collection.

PBSC risk due to transient low platelet counts (in case of mild constitutional thrombocytopenia, BM collection might be preferable), anticoagulation agents, venepuncture and potential immunomodulatory effect of G-CSF.

Transmission of bleeding disorder to recipient is clearly highly undesirable.

The duration and severity of illness – in particular, any need for supportive hospitalisation, anti-viral or antibody treatment, and any ongoing sequelae.
The date of full recovery.
The results of any post-recovery testing.

The last date of contact.
The nature of the contact.
The results of any post-contact testing.

There is no benefit to the patient as there is no evidence that detectable nasopharyngeal RNA is associated with infectious viraemia in a pre-symptomatic or symptomless SARS-CoV-2 infection.
There is no benefit to the donor or to collection staff if a result is not available early enough to prevent collection.

The donor is a volunteer who in most cases has already started or completed G-CSF conditioning.
There is a possibility of false positive results with rapid or instant screening assays.
The blood phase of COVID-19 is known to be difficult to detect in symptomatic patients, rarely detectable in pre-symptomatic patients, and there is no evidence for its infective potential.
Any delay in transplant that results from the cancellation or rejection of the donation will therefore disadvantage the patient with no known or likely risk of COVID-19 transmission.

Patients could be denied HPC products unnecessarily as a result of COVID-19 exposure that occurred after collection.
In the absence of symptoms, a positive nasopharyngeal swab on (for example) Day 14 post-collection or later is not consistent with the presence of pre-symptomatic COVID-19 infection at the time of collection.
Failed qualification due to the possibility of pre-symptomatic COVID-19 infection at the time of donation is not supported by evidence of transmissibility via blood or HPC during the pre-symptomatic phase.
Preliminary data from the NMDP/CIBMTR evaluated the effects of infusing products from COVID-19+ donors. No known infections of COVID-19 were reported among the patients who had products from COVID-positive donors infused. Moreover, there was no deleterious effects on neutrophil and platelet engraftment. The 3-month and 6-month overall survival were 100% (https://doi.org/10.1182/blood-2021-152952). This limited data reinforces that cryo-quarantine is NOT recommended.
Therefore withholding a donation for failed quarantine is detrimental to the patient because they lose their first-choice donor, and detrimental to the donor because their donation and associated community exposure has been in vain.

AFTER:	DONATION MAY BE COLLECTED:
COVID-19 infection	7 days after recovery from acute symptoms. For asymptomatic infections, 7 days after the first positive test result. For scheduling purposes, a healthy young volunteer donor can be expected to recover within a week, so it would be reasonable to schedule HPC or MNC collection 14 days following the onset of symptoms or the first positive test result.
Contact with COVID-19	7 days after a donor’s last contact with a person with COVID-19. Subject to risk assessment, a shorter waiting period may be considered – for example, where an asymptomatic donor tests negative after the minimum locally-required interval post-contact.

Condition

Disease of the vasculature of the brain. This includes:

Stroke, or cerebrovascular accident, whether haemorrhagic or embolic

Transient ischaemic attack

Intracerebral haemorrhage, including subarachnoid, subdural and extradural bleeds

Guidance at RECRUITMENT

UNACCEPTABLE

Guidance at CT/WORK-UP

UNACCEPTABLE, PERMANENT DEFERRAL

Individual at Risk

Donor

Justification for guidance

Both embolic stroke and intracerebral haemorrhage have been reported as adverse events in stem cell donors. In order to reduce this risk, it is prudent to defer any donor with a history of cerebrovascular disease or accident.

References

Halter J, Kodera Y, Ispizua AU, Greinix HT, Schmitz N, Favre G, et al. Severe events in donors after allogeneic hematopoietic stem cell donation. Haematologica 2009;94(1):94-101.

Condition

Chagas’ disease (Trypanosoma cruzi)

Individual at risk

Recipient

Guidance at RECRUITMENT for adult volunteer donor and maternal donor (cord blood donation)

A past history of Chagas’ disease should trigger permanent exclusion.

A history of being born or transfused with blood in a Chagas’ endemic area should trigger serological testing to quantify risk.

Guidance at CT/WORK-UP

A past history of Chagas’ disease may be acceptable if no evidence of acute or chronic infection, at the discretion of the requesting transplant centre.

A history of being born or transfused with blood in a Chagas’ endemic area should trigger serological testing to quantify risk.

A history of being transfused with blood in a Chagas’ endemic area should trigger serological testing to quantify risk.

Justification for guidance

The causative organism of Chagas’ disease is the protozoan Trypanosoma cruzi. The infection is a zoonosis that is transmitted to humans by bloodsucking insects of the Reduviidae family (kissing bugs), triatomine subfamily. The animal reservoir includes over 150 species of both wild and domestic mammals. Infection is life-long, but approximately 70% of infected individuals will remain asymptomatic. Furthermore, parasitaemia occurs not only during the acute phase of infection, but also during asymptomatic chronic phases (albeit intermittently and at low levels).

Accordingly, Chagas’ is well-known to be transfusion-transmissible and asymptomatic parasitaemia has been detected in blood donors. Cases of transmission via solid organ transplantation have also been reported. Though platelet concentrates are the most frequently reported means of transmission, T. cruzi is able to survive refrigeration, freezing and thawing.

Chagas’ is endemic to mainland Latin America; however, the common modes of transmission are such that the risk to travellers is minimal. Instead, the people most at risk are those who spend early childhood in an endemic area in certain types of dwelling, those who receive blood transfusions in endemic areas, and children whose mothers grew up at risk of Chagas’ disease. Most of this risk can be captured by asking donors their country of birth and whether they have ever received a blood transfusion in a Chagas’-endemic country. The former can be definitively captured at recruitment, while the latter could occur at any time up to work-up.

The detection of antibodies to T. cruzi is an established strategy to prevent transmission of infection through blood transfusion. Where available, this strategy can be adapted to assess the risk of prospective HPC donors with identified risk factors for chronic, asymptomatic Chagas’ disease. Because the prevalence of Chagas’ disease varies widely within the populations of endemic areas, it is likely that most donors with identified risk factors – especially those residing in non-endemic countries – will test negative for T. cruzi antibodies.

The most commonly used format for serological assays is the enzyme-linked immunosorbent assay (ELISA). A number of commercially available ELISAs are available and two have been licensed by the Food and Drug Administration (FDA) in the US. Other serological assay formats include particle agglutination (PA) and indirect haemagglutination assay (IHA). The Abbott Diagnostics ESA Chagas, an enzyme strip assay, is the only confirmatory assay to be approved by the FDA.

References

1 Kirchhoff LV. Trypanosoma Species (American Trypanosomiasis, Chagas’ Disease): Biology of Trypanosomes. In Mandell GL, Bennett JE and Dolin R, editors. Mandell, Douglas, and Bennett's Principles and Practice of Infectious Diseases. 6th ed, 2005:2622-2630.

2 Moncayo A and Silveira AC. Current epidemiological trends for Chagas disease in Latin America and future challenges in epidemiology, surveillance and health policy. Mem Inst Oswaldo Cruz 2009; 104 (Suppl. 1):17-30.

3 Teixeira AR, Hecht MM, Guimaro MC, Sousa AO, Nitz N. Pathogenesis of Chagas’ disease: parasite persistence and autoimmunity. Clin Microbiol Revs 2011; 24: 592-630.

4 Oliveira I, Torrico F, Munoz J and Gascon J. Congenital transmission of Chagas disease: a clinical approach. Expert Rev Anti Infect Ther 2010; 8:945-956.

5 Stramer SL, Hollinger, FB, Katz, LM, Kleinman, S, Metzel PS, Gregory KR, Dodd, R. Emerging infectious disease agents and their potential threat to transfusion safety. Transfusion. 49. August 2009. Supplement.

6 Schmunis GA. Epidemiology of Chagas disease in non-endemic countries: the role of international migration. Mem Inst Oswaldo Cruz 2007; 102 (Suppl.I):75-85.

7 Albajar-Vinas P. The hidden Chagas disease burden in Europe. Euro Surveill.2011;16(38):pii=19975.

8 Castro E. Chagas’ disease: lessons from routine donation testing. Transfusion Med 2009; 19:16-23.

9 Leiby DA, Herron RM Jr, Garratty G and Herwaldt BL. Trypanosoma cruzi parasitaemia in US blood donors with serologic evidence of infection. J Infect Dis 2008; 198:609-613.

10 CDC. Chagas disease after organ transplantation – Los Angeles, California, 2006. MMWR 2006; 55:798-800.

11 Bern C, Montgomery SP, Katz L, Caglioti S and Stramer SL. Chagas disease and the US blood supply. Curr Opin Infect Dis 2008; 21:476-482.

12 Primavera KS, Umezawa ES, Peres BA, Camargo ME, Hoshino-Shimizu S. Chagas'disease: IgA, IgM and IgG antibodies to T. cruzi amastigote, trypomastigote and epimastigote antigens in acute and in different chronic forms of the disease. Rev Inst Med Trop Sao Paulo. 1990 May-Jun;32(3):172-80.

13 Young C, Losikoff P, Chawla A, Glasser L and Forman E. Transfusion-acquired Trypanosoma cruzi infection. Transfusion 2007; 47:540-544.

Condition

COPD is characterized by persistent airflow limitation that is usually progressive and associated with an enhanced chronic inflammatory response in the airways and the lung to noxious particles or gases. Exacerbations and comorbidities contribute to the overall severity in individual patients. The condition is non reversible and can become more serious over time.

Individual at risk

Donor

Guidance at RECRUITMENT

UNACCEPTABLE

Proposed guidance at CT/WORK-UP

May be acceptable for PBSC only if mild disease (equivalent to GOLD I-II, FEV1>50%).

Justification for guidance

General anesthesia induces a significantly increased risk for postoperative pulmonary morbidity.

References

http://www.who.int/mediacentre/factsheets/fs315/en/index.html

Global Initiative for Chronic Obstructive Lung Diseases Pocket Guide to COPD Diagnosis, Management, And Prevention, 2013 (http://www.goldcopd.org)

Notes

Included in ICD-9 codes 490-496

Condition

Atherosclerotic or thrombotic occlusion of the coronary vasculature.

Pseudonyms and other related conditions include:

Angina

Ischaemic heart disease (IHD)

Myocardial infarction (MI)

Heart attack

Guidance at RECRUITMENT for adult volunteer donor (NA for maternal donor (cord blood donation))

UNACCEPTABLE

Guidance at CT/WORK-UP

UNACCEPTABLE, PERMANENT DEFERRAL

Individual at Risk

Donor

Justification

Myocardial infarction and angina have been well-documented as complications of both bone marrow and mobilised stem cell collection. In donors with known coronary artery disease, both processes pose an unacceptable risk to donor.

References

Halter J, Kodera Y, Ispizua AU, Greinix HT, Schmitz N, Favre G et al. Severe events in donors after allogeneic hematopoietic stem cell donation. Haematologica 2009; 94(1): 94-101.

Condition

Current sexual partner of person with hepatitis B infection

Individual at risk

Recipient

Guidance at RECRUITMENT for adult volunteer donor and maternal donor (cord blood donation)

Acceptable if donor can prove to be Hep B surface antibody positive

Guidance at CT/WORK-UP

Donor may be accepted only if donor is:

Donor is negative for all markers

OR

Donor is hep B core antibody positive, heb B surface antigen negative and hep B surface antibody has been documented to be present.

Justification for guidance

Hepatitis B infection is sexually transmitted and might be passed on to recipient by transplant of stem cells.

Notes

This advice is a requirement of the EU Tissues and Cells Directive.

Condition

Herpesvirus causing self-limiting infection in immunocompetent individuals, but with potentially severe consequences in immuno-suppressed transplant patients.

Individual at risk

Recipient

Guidance at RECRUITMENT

ACCEPTABLE

Guidance at CT

ACCEPTABLE

CMV IgG should be performed at CT to ascertain donor CMV serostatus.

Guidance at WORK-UP

Recommended testing at work-up:

CMV-IgG and IgM should be performed at work-up. If CMV IgM is postitive, CMV-PCR should be undertaken.

Testing outcomes and guidance

1)

CMV-IgM = negative, CMV-IgG = positive or negative

CMV-IgM = positive, CMV-IgG = positive, CMV-PCR negative

Status information should be reported to the transplant centre

With these combinations of serology and PCR, the donor can be cleared at workup. If there is a change of CMV status from CT to work-up stage, the transplant centre should be informed immediately.

CMV-IgG weak positive results should be validated with reference standard serology (e.g. immunoblot)

2)

CMV-IgM = positive and CMV-IgG = negative and CMV-PCR=negative

Immunoblots should be performed to validate the serology results. Results should be communicated with TC.

3) CMV-PCR = positive

Donor cannot be cleared. Inform transplant centre and discuss donor deferral

Justification for guidance

CMV can cause devastating complications in post-transplant recipients. Accurate donor CMV serostatus plays an important role in donor selection.

References

Pergam SA, Xie H, Sandhu R, et al. Efficiency and Risk Factors for CMV Transmission in Seronegative Hematopoietic Stem Cell Recipients. Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation. 2012;18(9):1391-1400. doi:10.1016/j.bbmt.2012.02.008. [1]

Notes

Page created 7th March 2015

Condition

Dengue fever

Individual at risk

Recipient

Guidance at RECRUITMENT

Accept any donor with a known history of dengue infection or travel to a dengue risk area.

Guidance at CT

Defer for 4 weeks after full recovery from dengue fever and following travel to any country that is endemic for dengue fever. For the purposes of HPC donor assessment, those countries can be considered to include all malaria-endemic countries plus:

• American Samoa • Antigua and Barbuda • Aruba • Bahamas • Barbados • Brunei • Caribbean Netherlands (Bonaire, Saba and Saint Eustatius) • Cook Islands • Cuba • Curacao • Dominica • Fiji • French Polynesia (including Tahiti, Moorea, Bora-Bora) • Grenada • Guadeloupe (France) • Jamaica • Kiribati • Maldives • Marshall Islands • Martinique • Micronesia (Federated States of) • Nauru • New Caledonia and dependencies (France) • Niue • Northern Mariana Islands • Pacific Islands of the United States, other (including Johnston Atoll, Wake Island, Midway Island) • Palau • Puerto Rico • Saint Barthelemy (France) • Saint Lucia • Saint Martin (France) • Samoa • Singapore • Sint Maarten (Netherlands) • Taiwan • Tokelau (New Zealand) • Tonga • Trinidad & Tobago • Turks and Caicos Islands • Tuvalu • Wallis & Futuna Islands (France)

In addition, certain countries with limited inhabited tropical regions (eg Australia) experience seasonal epidemics of dengue fever without the level of endemicity characterised by the occurrence of dengue haemorrhagic fever. When such a country provides a donor, there should be a process in place to capture any travel to a dengue-epidemic region, and to treat such travel the same way as travel to a dengue-endemic country.

Where a donor resides in an area with endemic dengue risk, the transplanting physician must balance the potential risk of dengue transmission with the availability of alternative transplantation options. In particular, the risk of dengue infection is generally seasonal, and there seems a relative paucity of transfusion-transmitted cases reported in the literature compared with the large disease burden caused by DENV.

Guidance at WORK-UP

Where possible, delay collection until at least 4 weeks following the donor’s return from the dengue risk area.

Where transplantation is urgent and an alternative donor is not available, the transplanting physician may take into consideration the fact that the incubation period for dengue fever is generally less than 14 days, and usually in the range of 4 to 7 days. However, symptoms might be masked by GCSF side affects and lab diagnostics take > 1 day, so transplant physicians should better consider "incubation period + 1 week" in urgent cases.

Justification for guidance

Dengue virus (DENV) is a highly emergent mosquito-borne virus that is responsible for a significant worldwide disease burden affecting some 2.5 billion (40%) of the world’s inhabitants in tropical areas of Asia, Oceania, Africa, Australia and the Americas.

In the last 50 years DENV incidence has increased 30-fold, and this massive expansion is closely related to the mosquito vector’s adaptation to urban environments. Hence dengue fever has become endemic in a number of developed urban areas in the tropics that have no malaria risk (eg Singapore), and thus the application of malaria exclusion criteria will not provide complete coverage of dengue risk.

Dengue fever classically presents as an acute febrile illness with sudden onset of severe headache, joint and muscle pain, nausea and vomiting. The incubation period following exposure to DENV can vary between 3-14 days (usually 4-7 days). A minority of cases progress to more severe forms such as dengue shock syndrome (DSS) and dengue haemorrhagic fever (DHF).

DHF is thought to result from an immunopathologic response in patients previously infected with a different serotype of dengue; hence may be considered an indicator of dengue endemicity.

However, the majority (50-85%) of DENV infections are asymptomatic. There is a known viraemic phase which can start 2-3 days prior to the emergence of symptoms and usually lasts 4-5 days during acute illness, but a viraemic period of up to 10 days has been reported.

There have been five reports of DENV transmission via blood transfusion – one in Hong Kong (2002), one in Puerto Rico (2007), and three in Singapore (2008). No DENV vaccine has yet been developed; treatment is generally supportive. No FDA licensed screening test is yet available. An NS1 antigen assay was submitted for FDA IND in 2010. A highly sensitive research nucleic acid testing (NAT) assay has been used for blood donor prevalence studies, however the manufacturer has not progressed to commercial release or submission for regulatory approval.

While the current “tropical diseases” policy effectively covers dengue risk, the length of the deferral (ie 6 months) and the huge geographical area affected (ie “tropical areas”, which would generally be defined as all latitudes between 35 degrees north and 35 degrees south) are both somewhat larger than necessary for dengue risk. “The tropics” includes many developed areas where prospective donors may reside, and in addition includes many popular tourism destinations. Therefore, a more targeted approach such the one proposed here could greatly increase potential donor eligibility with no significant increase in risk.

References

1. Vaughn DW, Green S, Kalayanawoj S, Innis BL, Nimmannitya S, Santayakorn S, Endy TP, Raengsakulrach B, Rothman AL, Ennis FA, Nisalak A. Dengue Viremia Titres, Antibody Response Pattern, Virus Serotype correlate with Disease Severity. JID 2000;181:2-9.

2. Stramer SL, Hollinger, FB, Katz, LM, Kleinman, S, Metzel PS, Gregory KR, Dodd, R. Emerging infectious disease agents and their potential threat to transfusion safety. Transfusion 2009; 49 (Supplement).

3. Seed CR, Kiely P, Hyland CA, Keller AJ. The risk of dengue transmission by blood during a 2004 outbreak in Cairns, Australia. Transfusion. 2009; 49:1482-7.

4. Linnen JM, Vinelli E, Sabino EC, Tobler LH, Hyland C, Lee TH, Kolk DP, Broulik AS, Collins CS, Lanciotti RS, Busch MP. Dengue viremia in blood donors from Honduras, Brazil, and Australia. Transfusion. 2008; 48:1355-62.

5. Mohammed H, Linnen JM, Munoz-Jordan JL, Tomashek K, Foster G, Broulik AS, Petersen L, Stramer SL. Dengue virus in blood donations, Puerto Rico, 2005. Transfusion. 2008; 48:1348-54.

6. Teo D, Ng LC, Lam S. Is dengue a threat to the blood supply? Transfusion Med 2009; 19:66–77.

7. Chuang VW, Wong TY, Leung YH, Ma ES, Law YL, Tsang OT, Chan KM, Tsang IH, Que TL, Yung RW, Liu SH. Review of dengue fever cases in Hong Kong during 1998 to 2005. Hong Kong Med J. 2008; 14:170-7.

8. Guzman MG, Kouri G. Dengue: an update. Lancet Infect Dis. 2002; 2:33-42.

9. Stramer SL, Linnen M, Carrick M et al. Dengue donor viremia determined by RNA and NS1 antigen, and detection of dengue transfusion transmission during the 2007 dengue outbreak in Puerto Rico (abstract). Vox Sang (2010); 99 Supplement 1:32.

Condition

Depression, whether endogenous or exogenous in origin.

Individual at Risk

Donor / recipient

Guidance at RECRUITMENT for adult volunteer donor and maternal donor (cord blood donation)

ACCEPTABLE

Guidance at CT / WORK-UP

ACCEPTABLE if not currently depressed, or if depression adequately treated with medication or counselling. Ask the following questions:

Can the donor work and travel?

Could the donor cope with a hospital stay if required to donate?

Could the donor cope with pressures involved with donating, as donation may be a stressful procedure for some individuals?

If the answer to these questions are yes, than accept.

Specific guidance for those taking selective serotonin reuptake inhibitors

There is some concern over an impact of selective serotonin reuptake inhibitors on platelet function. In most studies this is manifest as an increase in gastrointestinal bleeding, particularly in those taking non-steroidal anti-inflammatory drugs or coumarins, with no evidence supporting an increase in intracerebral haemorrhage. However, for this reason, donors taking these medicines should be strongly advised to avoid concurrent non-steroidal anti-inflammatory (NSAID) therapy have close platelet monitoring and receive attentive follow-up should they become significantly thrombocytopenic following apheresis.

However, there is no evidence to suggest an increased bleeding risk during bone marrow harvest.

Justification for guidance

Depression is common, and the majority of depressed donors will be able to donate. There is anecdotal evidence of depressed donors withdrawing from donation at the last minute, but this behaviour has also been seen in non-depressed donors and forms no basis for deferral. There is no evidence that depressed donors have impaired capacity for informed consent.

References

Dall M, Hallas J. [Is the use of selective serotonin reuptake inhibitors associated with an increased risk of bleeding?]. Ugeskr Laeger 2006; 168(23): 2232-6.

Schalekamp T, Klungel OH, Souverein PC, de Boer A. Increased bleeding risk with concurrent use of selective serotonin reuptake inhibitors and coumarins. Arch Intern Med 2008; 168(2): 180-5.

Serebruany VL. Selective serotonin reuptake inhibitors and increased bleeding risk: are we missing something? Am J Med 2006; 119(2): 113-6.

Individual at risk

Donor

Guidance at RECRUITMENT

UNACCEPTABLE

Guidance at CT/WORK-UP

ACCEPTABLE if type II diabetes controlled with diet or oral medication alone, and no other risk factors for cardiovascular disease are present.

DEFER if type I diabetes/MODY, or type II diabetes requiring insulin.

Justification for guidance

a) The results of antibody testing (if performed).

b) The reported malaria risk factor, including the date of last exposure/treatment cessation.

c) The interval between last exposure/treatment cessation and the date of testing (if performed), and the likely testing window period (typically 4 months for serological testing).

For positive results, the donor should be notified and counselled.

Condition

The term eczema may describe a range of persistent skin conditions, including dryness and recurring skin rashes that are characterized by one or more of these symptoms: redness, skin edema (swelling), itching and dryness, crusting, flaking, blistering, cracking, oozing, or bleeding.

Individual at risk

Donor / recipient

Guidance at RECRUITMENT for adult volunteer donor and maternal donor (cord blood donation)

Acceptable if not requiring systemic (i.e. tablet) therapy (including oral steroids and other immunosuppressive agents). Topical steroids (i.e. creams appied to the skin) are acceptable. Check if given ultraviolet (PUVA) therapy, which may otherwise require donor deferral.

Guidance at CT/WORK-UP

Acceptable if not requiring systemic (i.e. tablet) therapy (including oral steroids and other immunosuppressive agents). Topical steroids (i.e. creams appied to the skin) are acceptable. Check harvest sites are not involved (inside elbows, back of hips). Check if given ultraviolet (PUVA) therapy.

Inform transplant centre if the donor has eczema.

Justification for guidance

There is a risk of transfer of atopic conditions to the recipient, although only a few cases have been described in the literature, and not eczema specifically. G-CSF may theoretically cause a flare of any inflammatory condition, including eczema, although this is likely to return to normal following donation.

References

Hallstrand TS, Sprenger JD, Agosti JM, Longton GM, Witherspoon RP, Henderson WR, Jr. Long-term acquisition of allergen-specific IgE and asthma following allogeneic bone marrow transplantation from allergic donors. Blood 2004; 104(10): 3086-90.

Condition

Endometriosis is a condition that is caused by endometrium growing outside the uterus. Mostly in ovaries, the Fallopian tubes and tissue surrounding the uterus. Most common and directly related symptoms are pain (which can vary in intensity, site, triggers, timing and duration). Anemia is associated with endometriosis due to menorrhagia. Based on retrospective studies there seems to be an increased risk for the development of ovarian cancer, but preventative measures are not advised.

Guidance at RECRUITMENT

Accept, if pain well controlled with acceptable medication and not anemic.

Guidance at CT/WORK-UP

Accept, if pain well controlled with acceptable medication and not anemic.

Individual at Risk

Potentially donor

Justification for guidance

Because G-CSF can be used for thin endometrium associated with infertility (usually infused directly into the uterine cavity) a role of G-CSF in exacerbation or triggering endometriosis can be suspected. However, because the site of administration in PBSC donation is different and there are no published warnings about G-CSF in endometriosis at this moment uncomplicated endometriosis is not considered a contra-indication for both forms of donation.

References

Donor suitability working group WMDA meeting Munich 2018.

Zondervan KT, Becker CM, Koga K, Missmer SA, Taylor RN, Viganò P. Endometriosis. Nat Rev Dis Primers. 2018 Jul 19;4(1):9. doi: 10.1038/s41572-018-0008-5.

Eftekhar M, Naghshineh E, Khani P. J Role of granulocyte colony-stimulating factor in human reproduction. Res Med Sci. 2018 Jan 29;23:7. doi: 10.4103/jrms.JRMS_628_17. eCollection 2018.

Heidemann LN, Hartwell D, Heidemann CH, Jochumsen KM. The relation between endometriosis and ovarian cancer - a review. Acta Obstet Gynecol Scand. 2014 Jan;93(1):20-31. doi: 10.1111/aogs.12255. Epub 2013 Oct 9.

Condition

Epilepsy is a chronic neurological disorder characterized by recurrent brief episodes of involuntary shaking (seizures) which may involve a part of the body (partial) or the entire body (general).

Individual at risk

Donor

Guidance at RECRUITMENT

ACCEPT if seizure-free for the previous 12 months WITHOUT medication.

DEFER if currently requiring medication

Guidance at CT/WORK-UP

ACCEPT if seizure-free for the past 12 months WITHOUT medication. Inform the anaesthetist at work-up of seizure history.

DEFER if currently requiring medication.

Justification for guidance

There is a potential increased risk for perioperative seizures due to the pre-existent condition or the proconvulsant effect of anaesthetic drugs, and also due to electrolyte changes experience during apheresis.

Anticonvulsant medications may cause abnormalities in blood counts, which may exacerbate those seen after PBSC.

References

http://www.who.int/mediacentre/factsheets/fs999/en/index.html

Benish SM, Cascino GD, Warner ME, Worrell GA, Wass CT. Effect of general anesthesia in patients with epilepsy: a population-based study. Epilepsy Behav 2010; 17(1): 87-9.

Notes

ICD code 345

Condition

Herpes virus causing glandular fever (infectious mononucleosis).

Individual at risk

Recipient (and ?donor)

Guidance at RECRUITMENT

ACCEPTABLE

Guidance at CT

ACCEPTBALE

Guidance at WORK-UP

The following serological tests should be obtained

• VCA-IgM

• VCA-IgG

• (EBNA-IgG)

If VCA-IgM is positive, EBV-PCR should be undertaken

Outcomes and recommended actions based on EBV serology and PCR:

Potential serology/PCR combinations:

1) VCA-IgM neg AND VCA-IgG pos or neg.

OR

VCA-IgM-pos AND VCA-IgG pos AND EBV-PCR = negative

Donor can be cleared - transplant centre should be informed for serological/PCR status

2) VCA-IgM-pos AND VCA-IgG and/or EBNA weak or negative AND EBV-PCR=negative

IgM could be non-specific or donor has acute (inapperent) infection

The clinical picture (e.g. sore throat, swollen lymph glands) as well as laboratory parameters (lymphocytosis, atypical lymphocytes on blood smear) should be correlated with serology, and taken into account for reasons of donor safety. Consider more specific immunoblots to validate the serology results. Results should be communicated with transplant centre.

3) EBV-PCR = positive

Donor cannot be cleared at the current timepoint. Inform transplant centre and discuss potential donor deferral.

Justification for guidance

Primary EBV infection or reactivation in a transplant recipient is associated with post-transplant lymphoproliferative disease, amongst other morbidity.

References

Buisson, M., Fleurent, B., Mak, M., Morand, P., Chan, L., Ng, A., … Seigneurin, J. M. (1999). Novel Immunoblot Assay Using Four Recombinant Antigens for Diagnosis of Epstein-Barr Virus Primary Infection and Reactivation. Journal of Clinical Microbiology, 37(8), 2709–2714. [1]

APA Recommendations of the Center for International Blood and Marrow Transplant Research (CIBMTR®), the National Marrow Donor Program (NMDP), the European Blood and Marrow Transplant Group (EBMT), the American Society of Blood and Marrow Transplantation (ASBMT), the Canadian Blood and Marrow Transplant Group (CBMTG), the Infectious Disease Society of America (IDSA), the Society for Healthcare Epidemiology of America (SHEA), the Association of Medical Microbiology and Infectious Diseases Canada (AMMI), and the Centers for Disease Control and Prevention (CDC), Tomblyn, M., Chiller, T., Einsele, H., Gress, R., Sepkowitz, K., … Boeckh, M. A. (2009). Guidelines for Preventing Infectious Complications among Hematopoietic Cell Transplant Recipients: A Global Perspective. Biology of Blood and Marrow Transplantation : Journal of the American Society for Blood and Marrow Transplantation, 15(10), 1143–1238. doi:10.1016/j.bbmt.2009.06.019 [2]

Notes

Page created 7th March 2015

Medical guideline recommendation

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Condition

Fibromyalgia is a disorder of unknown etiology characterized by widespread pain, abnormal pain processing, sleep disturbance, fatigue and often psychological distress. People with fibromyalgia may also have other symptoms; such as, morning stiffness, tingling or numbness in hands and feet, headaches, irritable bowel syndrome, sleep disturbance, cognitive problems with thinking and memory, painful menstrual periods and other pain syndromes. Causes and/or risk factors for fibromyalgia are unknown, but some things have been loosely associated with disease onset: stressful or traumatic events, such as car accidents, post traumatic stress disorder, repetitive injuries, illness (e.g. viral infections), certain diseases (i.e., SLE, RA, chronic fatigue syndrome), genetic predisposition, obesity, neurotransmitter disorders and genetic metabolic disorder. People with fibromyalgia react strongly (abnormal pain perception processing) to things that other people would not find painful.

Individual at risk

Donor / Recipient

Guidance at RECRUITMENT for adult volunteer donor and maternal donor (cord blood donation)

DEFER

Guidance at CT/WORK-UP

DEFER FOR BONE MARROW AND PBSC

Justification for guidance

Due to the fact that the disease does not have a well defined etiology donor as well as recipient may be at risk during or after stem cell donation. The tendency of patients to react strongly to things that other people would not find painful is another justification for deferral for donation.

References

Fibromyalgia Case Definition. Centre for Disease Control, November 7th 2012, retrieved February 2nd 2013

SmithHS, Harris R, Clauw D. Fibromyalgia: an afferent processing disorder leading to a complex pain generalized syndrome. Pain Physician 2011;14(2):E217-45.

Neumann L, Buskila D. Epidemiology of fibromyalgia. Curr Pain Headache Rep 2003;7(5):362–368.

Arnold LM, Hudson JI, Hess EV, Ware AE, Fritz DA, Auchenbach MB, Starck LO, Keck PE. Family study of fibromyalgia. Arthritis Rheum 2004;50(3):944-952.

Mork PJ, Vasseljen O, Nilsen TI. Association between physical exercise, body mass index, and risk of fibromyalgia: longitudinal data from the Norwegian Nord-Trøndelag Health Study. Arthritis Care Res (Hoboken). 2010; May;62(5):611-7. ed syndrome. Pain Physician 2011;14(2):E217-45.

Condition

Former sexual partner of person with hepatitis B infection

Individual at risk

Recipient

Guidance at RECRUITMENT for adult volunteer donor and maternal donor (cord blood donation)

Obtain history and refer to designated medical officer.

Guidance at CT/WORK-UP

Donor may be accepted only if donor is negative for all markers or HB core antibody positive, HbsAg negative and antiHBs has been documented at more than 100 iu/l at some time.

Justification for guidance

Hepatitis B infection is sexually transmitted and might be passed on to recipient by transplant of stem cells.

Notes

This advice is a requirement of the EU Tissues and Cells Directive.

Condition

Basic information

Chronic optic nerve damage, characteristically associated with unstable or a sustained increase in the intraocular pressure

Types

(Primary) open-angled glaucoma

(Primary) angle-closure glaucoma

Secondary glaucoma:

Drug-induced (corticosteroids)

Neovascular (diabetic retinopathy)

Inflammatory (iritis)

Traumatic / postsurgical

Developmental glaucoma

Individual at risk

Donor

Guidance at RECRUITMENT

Eligible if stable and well-controlled

Ineligible if progressive loss of vision or tendency to acute glaucoma attacks / angle-closure crisis

Guidance at CT / WORK-UP

Eligible if stable and well-controlled

HIV infection is sexually transmitted and might be passed on to recipient by transplant of stem cells. Furthermore, patients undergoing stem cell transplantation are immunocompromised and are therefore at high risk of complications if infected with HIV.

Since peoples’ sexual practices change over time, and since the window period for HIV detection is less than three months, a sexual history is not necessary at the time of recruitment and need only be taken from potential donors at the time of confirmatory typing and workup assessment. Furthermore, individuals should not be deferred at time of recruitment due to behavioural risk factors for infectious disease.

Although HIV testing is performed at confirmatory typing and workup assessment, such testing will not capture window period infections that could result in transmission of HIV to the patient.

While pre-exposure prophylaxix (PrEP) or post-exposure prophylaxis (PEP) medications are highly effective at preventing HIV transmission when used as prescribed, these medications are not 100% effective, and it is possible for an individual to become infected with HIV while taking them. If PrEP/ PEP is not used as prescribed, there is a greater chance for becoming infected with HIV. This is called a “breakthrough” HIV infection. Additionally, PrEP/ PEP interfere with accurate HIV testing: if an individual is HIV-positive, these medications may cause the HIV viral load in the blood to temporarily drop to a level that cannot be detected but could still be transmitted to a patient. Therefore, individuals on PrEP/ PEP are deferred from donation (see Medications- PrEP/ PEP).

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v. 22	May 22, 2024 19:42	WMDA update system	e4553ff5267525c6e7b9a4253e614087
v. 21	May 22, 2024 19:42	Riny Heijdendael

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Individual at risk

Recipient

Guidance at RECRUITMENT for adult volunteer donor and maternal donor (cord blood donation)

Acceptable

Guidance at CT/WORK-UP

Acceptable if more than 3 months from last sexual contact with a person living with HIV.

However, this time period may be shortened at the discretion of the requesting transplant centre.

Justification for guidance

HIV infection is sexually transmitted and might be passed on to recipient by transplant of stem cells.

Since peoples’ sexual practices change over time, and since the window period for HIV detection is less than 3 months, a sexual history is not necessary at the time of recruitment and need only be taken from potential donors at the time of confirmatory typing and workup assessment. Furthermore, individuals should not be deferred at time of recruitment due to behavioral risk factors for infectious disease.

A period of 3 months since last possible exposure to infection obviates the risk of window period transmissions.

Version	Published	Changed By	Comment
CURRENT (v. 14)	May 22, 2024 19:44	Riny Heijdendael
v. 22	May 22, 2024 19:42	WMDA update system	e4553ff5267525c6e7b9a4253e614087
v. 21	May 22, 2024 19:42	Riny Heijdendael

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Condition

HTLV-I and HTLV-II are closely related RNA retroviruses that are transmitted parenterally and sexually, and typically cause life-long chronic infection.

Individual at risk

Recipient

Guidance at RECRUITMENT for adult volunteer donor and maternal donor (cord blood donation)

PERMANENT DEFERRAL

Notify and counsel donor

Guidance at CT/WORK-UP

PERMANENT DEFERRAL

Notify and counsel donor

Justification for guidance

HTLV-I is associated with a small risk of myelopathy and other inflammatory conditions, but more importantly causes immune suppression with consequent risk of cancer and opportunistic infections.

HTLV-II is less common and has no firmly established disease association, but it would be wise to assume that similar immune effects to HTLV-I could occur.

HTLV-I is efficiently transmitted via blood products, with lookback studies suggesting a transmission rate of 13-75%. With the virus’ predilection for CD4+ T-helper cells, this efficiency may be even greater for haematopoietic stem cell products.

Considering that HSCT recipients already face a high degree of immune suppression and concomitant cancer/infection risk, it would seem reasonable to maintain the current recommendation of permanent exclusion of donors with HTLV-I or HTLV-II.

References

Goncalves DU, Proietti FA, Ribas JGR, Araujo MG, Pinheiro SR, Guedes AC and Carneiro-Proietti BF. Epidemiology, treatment, and prevention of human T-cell leukemia virus type 1-associated diseases. Clin Microbiol Revs 2010; 23:577-589.

Manns A, Wilks R, Murphy EL, Haynes G, Figueroa P, Barnett M, Hanchard B and Blattner WA. A prospective study of transmission of HTLV-I and risk factors associated with seroconversion. Int J Cancer 1992; 51:886-891.

Boxus M and Willems L. Mechanisms of HTLV-I persistence and transformation. Br J Cancer 2009; 101:1497-1501.

Namen-Lopes MSS, Martins ML, Drummond PC, Lobato RR, Interdisciplinary HTLV Research Group (GIPH) and Carneiro-Proietti ABF. Lookback study of HTLV-1 and 2 seropositive donors and their recipients in Belo Horizonte, Brazil. Transfusion Med 2009; 19:180-188.

Notes

There may also be legal and/or regulatory issues with the collection, transport and administration of a HTLV-positive product.

Condition

Inherited haemoglobin disorders are endemic through Africa, South-East Asia and the Caribbean and the Mediterranean, where the high allelic frequency offers some protection against infectious disease, particularly malaria. They are conventionally divided into disorders of haemoglobin structure (e.g. sickle cell) and haemoglobin production (e.g. the thalassaemias).

By their nature, inherited haemoglobin disorders will always be acquired the recipient of a haematopoietic stem cell transplant, assuming engraftment occurs. However, many carrier states and compound heterozygotes have a clinical silent disease which may be well-tolerated by the recipient. In addition, for ethnic minority recipients who may have an extremely limited choice of donors, the risk of an acquired haemoglobinopathy may be outweighed by the chance of cure.

See here for

Individual at Risk

Recipient

Guidance for CORD BLOOD DONATION

Must not donate if: mother or father homozygous or heterozygous for inherited haemoglobin disorders and infant affected.

Discretionary: If the cord blood or infant/child is tested for the condition and the infant is shown to be unaffected or heterozygous (trait), accept and inform the transplant centre.

Guidance at RECRUITMENT

QUALIFIED, see below

Acceptability at CT / Work-Up

QUALIFIED, see below

Guidance

Each donor with a haemoglobinopathy should be assessed by a physician on a case-by-case basis. In general:

Unacceptable

Thalassaemia major or intermedia

Sickle cell disease (HbSS, HbSC, HbSBthal, HbSD)

High affinity haemoglobin

Other clinically significant structural or functional haemoglobinopathies.

Acceptable if haemoglobin is within normal sex-adjusted range, at the discretion of the transplant centre

Alpha or beta thalassaemia trait

Sickle cell trait

HbC, HbDPunjab/Oman, HbE traits

Other asymptomatic traits or compound heterozygotic haemoglobinopathies e.g. HbC/a-thal trait.

Sickle cell trait

There is no evidence of clinically significant sickling during mobilized PBSC collection in those with sickle cell trait. However, clumping of sickle cells has been observed during post-collection processing. In these circumstances, it is advisable that donors with sickle cell trait should donate by BM.

References

Kang EM, Areman EM, David-Ocampo V, Fitzhugh C, Link ME, Read EJ et al. Mobilization, collection, and processing of peripheral blood stem cells in individuals with sickle cell trait. Blood 2002; 99(3): 850-5.

Castro O, Hardy KP, Winter WP, Hornblower M, Meryman HT. Freeze preservation of sickle erythrocytes. Am J Hematol 1981; 10(3): 297-304.

Meryman HT, Hornblower M. Freezing and deglycerolizing sickle-trait red blood cells. Transfusion 1976; 16(6): 627-32.

Adler BK, Salzman DE, Carabasi MH, Vaughan WP, Reddy VV, Prchal JT. Fatal sickle cell crisis after granulocyte colony-stimulating factor administration. Blood 2001;97(10):3313-4.

Condition

Hereditary haemochromatosis is an autosomal recessive disorder most frequently associated with mutations of the HFE gene. The estimated incidence of the C282Y mutation is 10% in people of northern European descent. In that population, about 1% have the condition. Secondary iron overload may be the result of repeated blood transfusion. Persistent iron overload may eventually lead to organ damage especially of the heart, liver and endocrine organs. HFE genes are not expressed in hematopoietic stem cells.

Guidance at RECRUITMENT

Accept, if no end-organ failure

Guidance at CT

Accept, if no end-organ failure

Guidance at CT/WORK-UP

Accept, if no end-organ failure

Individual at Risk

Because the associated genes are not expressed in the hematopoietic pool there is no risk of transmitting the disease to the recipient. Iron overload in itself does not impose risk for the donor or the recipient. The donor is only at risk if there is organ damage which increases the risk of complications of the stem cell donation. In case of secondary iron overload the underlying condition must be evaluated.

Justification for guidance

The donor is only at risk if there is organ damage, which increases the risk of complications of the stem cell donation. Iron overload in itself does not impose risk for the donor or the recipient.

References

Donor suitability working group WMDA meeting Munich 2018.

Andrews, Nancy C. (1999). "Disorders of Iron Metabolism". New England Journal of Medicine. 341 (26): 1986–95. doi:10.1056/NEJM199912233412607. PMID 10607817.

Pietrangelo, A (2003). "Haemochromatosis". Gut. 52 (90002): ii23–30. doi:10.1136/gut.52.suppl_2.ii23. PMC 1867747 Freely accessible. PMID 12651879.

Franchini, Massimo (2006). "Hereditary iron overload: Update on pathophysiology, diagnosis, and treatment". American Journal of Hematology. 81 (3): 202–9. doi:10.1002/ajh.20493. PMID 16493621.

Individual at risk

Recipient

Condition

Current hepatitis B infection

Guidance at RECRUITMENT for adult volunteer donor and maternal donor (cord blood donation)

Unacceptable

Guidance at CT/WORK-UP

Unacceptable.

Justification for guidance

Hepatitis B infection is transmissible by transfusion of blood and stem cells.

Notes

This advice is a requirement of the EU Tissues and Cells Directive.

Condition

History of previous hepatitis B infection

Individual at risk

Recipient

Guidance at RECRUITMENT for adult volunteer donor and maternal donor (cord blood donation)

Acceptable if more than 12 months have past since infection, and the donor has documented Anti-hepatitis B surface antibody >100iu/L.

Guidance at CT/WORK-UP

If less than 12 months since recovery from acute infection, defer.

If more than 12 months from recovery, obtain history and blood samples.

Donors with a definite or possible previous history of hepatitis B (whether known or not) may be accepted if:

Donor is negative for all markers

OR

Donor is hep B core antibody positive, heb B surface antigen negative and hep B surface antibody has been documented to be more than 100 iu/l at some time.

Inform requesting transplant centre if donor history or serological markers suggest a previous hepatitis B infection.

Justification for guidance

Hepatitis B infection is transmissible by transfusion of blood and stem cells.

Notes

This advice is a requirement of the EU Tissues and Cells Directive.

Condition

Current sexual partner of person with hepatitis C infection

Individual at risk

Recipient

Guidance at RECRUITMENT for adult volunteer donor and maternal donor (cord blood donation)

Obtain history and refer to designated medical officer

If donor’s HCV positive partner has been successfully treated for HCV infection and has been free of therapy fo 12 months and continues in sustained remission, donor is acceptable.

Guidance at CT/WORK-UP

If donor’s HCV positive partner has been successfully treated for HCV infection and has been free of therapy for 12 months and continues in sustained remission, donor is acceptable.

Unacceptable.

Individuals who have had hepatitis C in the past will usually remain HCV antibody positive for many years even if their infection has been successfully treated. A negative HCV screening test is required before a donation can be issued.

Guidance at CT/WORK-UP

Donors who are HCV antibody positive but negative for HCV RNA may be acceptable at the discretion of the requesting transplant centre.

Justification for guidance

Hepatitis C infection is transmissible by transfusion of blood and stem cells.

Created by Lydia Foeken, last modified on 26 April, 2024, 17.15

Acute infection (= HEV-RNA detectable, not IgG-positivity)

At recruitment (only if donor reports, no test required):

At CT (only if donor reports, no test required)

If entirely free of symptoms, re-evaluation is possible after 2 months
If lasting hepatitis-like symptoms like fatigue, elevated liver enzymes, chronic HEV infection should be excluded (defined as persisting viremia >3 months)

At WU/PE (if test required by local regulations, or if medically appropriate, e g recent travel history)

If entirely free of symptoms, re-evaluation is possible after 2 months. Consult with TC.
If lasting hepatitis-like symptoms like fatigue, elevated liver enzymes, chronic HEV infection should be excluded (defined as persisting viremia >3 months)
Testing available to TC

At collection day / in the product (if test required by local regulations, or if medically appropriate, e g recent travel history; results will typically be available only after donation)

INFORM transplant centre immediately, if positive result.
Do not discard the product, but leave the decision to transfuse to the transplant centre
As transplant centres might not be familiar with HEV, communicate that it might be acceptable to use the product after risk/benefit assessment, especially if the recipient has already been exposed to HEV.

Chronic infection

Background:

References

1. Facts about hepatitis E. European Centre for Disease Prevention and Control. https/www.ecdc.europa.eu/en/hepatitis-e/facts.
A.S. de Vos et al. Cost Effectiveness of the screening of blood donations for hepatitis E virus in the Netherlands. Transfusion Vol 57, February 2017.
JK Mah et al. Hepatitis E virus seropositivity in an ethnically diverse community blood donor population. Vox Sanguinis. 2023;1–7.
R S Tedder et al. Hepatitis E risks: pigs or blood—that is the question. Volume 57, February 2017 Transfusion
E Spada et al. A nationwide retrospective study on prevalence of hepatitis E virus infection in Italian blood donors. Blood Transfusion 2018; 16: 413-21 DOI 10.2450/2018.0033-18
Domanović D et al. Hepatitis E and blood donation safety in selected European countries: a shift to screening? Euro Surveill. 2017 Apr 20;22(16):30514. doi: 10.2807/1560-7917.ES.2017.22.16.30514. PMID: 28449730; PMCID: PMC5404480.

Condition

Hereditary elliptocytosis (HE) aka hereditary ovalocytosis, is a heterogeneous group of inherited red blood cell (RBC) disorders characterized by elongated, oval, or elliptically shaped RBCs on peripheral blood smear. Hemolytic anemia in these disorders can range from absent to life-threatening.

Guidance at RECRUITMENT

ACCEPTABLE

Guidance at CT/WORK-UP

Accept, if no clinically significant hemolysis, at the discretion of transplant center.

Unacceptable if active hemolysis.

Justification for guidance

Hemolytic anemia poses risk to both donor and recipient. If no evidence of hemolysis, inform transplant center of diagnosis and proceed if TC prefers. Donor must not donate if clinically significant hemolysis.

References

Donor suitability working group WMDA meeting Hanau 2023.

Kalfa, T., Takemoto, C., & Tirnauer, J. (2023). Hereditary elliptocytosis and related disorders. UpToDate. Retrieved October 10, 2023 from

https://www.uptodate.com/contents/hereditary-elliptocytosis-and-related-disorders?search=hereditary%20elliptocytosis&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1

Version	Published	Changed By	Comment
CURRENT (v. 14)	May 22, 2024 19:44	Riny Heijdendael
v. 22	May 22, 2024 19:42	WMDA update system	e4553ff5267525c6e7b9a4253e614087
v. 21	May 22, 2024 19:42	Riny Heijdendael

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Condition

HSV-1 and -2 are DNA viruses from Herpesviridae family, causing life-long chronic latent infection. Virus may reactivate from time to time. Both are transmitted by contact with an infected area of the skin, during viral re-activations periods, while facial or genital sores are present. Normally HSV is not transmitted via blood or bone marrow.

Individual at risk

Recipient

Guidance at RECRUITMENT

ACCEPTABLE

Guidance at CT

ACCEPTABLE

Guidance at WORK-UP

Generally accepted, but would be preferable to postpone the collection if active face or genital sores are present. After recovery – usually 2 weeks - collection should be possible (better, when cold sore is dry and not tingling, otherwise the virus may still be replicating). Aciclovir or other antiviral locally may be used to shorten the recovery time.

If recipient has started conditioning, treat donor with aciclovir, inform transplant centre and proceed with collection.

Justification for guidance

In healthy individuals HSV 1 & 2 infection and viral reactivation causes only slight local lesions – sores. If transmitted to immunocompromised patient, HSV may cause severe infectious complications, including meningitis or respiratory infections.

There may be HSV viraemia during primary HSV infection or reactivation. Hence it is preferable to delay donation (where possible) until lesions are healing. Most recipients will routinely receive prophylactic aciclovir which should afford them some protection.

References

Whitley RJ, Roizman B. Herpes simplex virus infections. Lancet 2001; 357: 1513–1518. [1]

Juhl D, Mosel C, Nawroth F, Funke AM, Dadgar SM, Hagenstrom H, Kirchner H, Henning H. Detection of herpes simplex virus DNA in plasma of patients with primary but not with recurrent infection: implications for transfusion medicine? Transfus Med 2010 Feb: 20(1)38-47 [2]

Styczynski J, Reusser P, Einsele H, de la Camara R, Cordonnier C, Ward K N, Ljungman P and Engelhard D for the European Conference on Infections in Leukemia. Management of HSV, VZV and EBV infections in patients with hematological malignancies and after SCT: guidelines from the Second European Conference on Infections in Leukemia. Bone Marrow Transplantation (2009) 43, 757–770 [3]

Notes

In case the partner has an active sore, donor has to be advised to avoid direct contact within the WU and collection period.

Condition

High-risk sexual behaviour is that which puts the donor at risk of infectious diseases which may then be transmitted to the recipient/patient. This risk occurs because the donor themselves currently participate in high-risk behaviour, or currently have sex with someone from a high-risk background.

The aim is to reduce the risk of 'window period' transmissions, where a donor is infected with (for example) HIV, but the infection is too recent to be picked up by screening tests and the infection is passed to the patient. For this reason, donors who have participated in high risk sexual behaviour say over one year ago, but do not do so currently, should be allowed to donate.

There is no strict definition of what high-risk behaviour/background is, but it would include those who have unprotected vaginal or anal sex with multiple partners (with a higher risk in men who have sex with men), those who pay (or are paid) for sex, those from an geographical area with a very high prevalence of HIV, and those with other sexually transmitted diseases.

Unprotected sex within a monogamous relationship is not necessarily seen as high-risk behaviour, regardless of whether it is a male homosexual relationship or not, if both partners remain monogamous during a set time-frame.

Individual at Risk

Recipient

Guidance at RECRUITMENT

UNACCEPTABLE

Guidance at CT/WORK-UP

TEMPORARY DEFERRAL

Pain or underlying condition may be aggravated or triggered by bone marrow collection.

Inform transplant centre if medically suitable for PBSC only.

Condition

High blood pressure.

Individual at risk

Donor

Guidance at RECRUITMENT

ACCEPTABLE

Guidance at CT/WORK-UP

ACCEPTABLE if well controlled. However, the presence of other cardiovascular risk factors should also be considered.

A threshold should be set by the registry for upper limits of systolic and diastolic blood pressure.

If above this threshold, the donor should be temporarily deferred until the hypertension is controlled. If medication is initiated or recently changed (< 4 weeks), or if hypertension is under investigation, the donor should also be temporarily deferred.

Number or types of drugs should not influence deferral if blood pressure is well controlled.

Justification for guidance

Uncontrolled hypertension increases the risk of heart failure, myocardial infarction, stroke, and kidney damage.

References

Carretero OA, Oparil S. Essential hypertension. Part I: definition and etiology. Circulation 2000; 101(3): 329-35.

Condition

Uveitis (iritis, iridocyclitis, chorioretinitis); scleritis; (episcleritis); (conjunctivitis)

Basic information

Inflammation affecting parts of one or both eyes

Causes:

Infectious: Toxoplasmosis, CMV, leptospirosis, tuberculosis

Isolated autoimmune or non-infectious: HLA-B27 associated, traumatic/sympathetic ophthalmopathy, drug-induced

Associated with systemic diseases: Behçet's disease, arthritis, connective tissue diseases

Individual at risk

Donor; Recipient (if infectious or presumed transmission of autoimmune diseases)

Guidance at RECRUITMENT

NOT ACCEPTABLE if acute or chronic inflammatory process, unless transient viral conjunctivitis.

NOT ACCEPTABLE if there is associated systemic disease

ACCEPTABLE for BM only if recurring inflammation or increased risk for recurrence (HLA-B27) or exacerbation (toxoplasmic chorioretinitis) (if registry policy allows registration for BM only)

Proposed guidance at CT / WORK-UP

NOT ACCEPTABLE if acute or chronic inflammatory process

NOT ACCEPTABLE if there is associated systemic disease

ACCEPTABLE for BM only if recurring inflammation or increased risk for recurrence (HLA-B27) or exacerbation (toxoplasmic chorioretinitis)

Justification for guidance

Uveitis has been reported as side effect of GCSF.

Infectious eye diseases can aggravate years after initial treatment, and the role of GCSF in response to infectious agents is not fully understood.

History of eye inflammation in association with systemic diseases usually requires deferral due to the underlying condition. If such an association cannot be excluded at medical examination, consider BM only or temporary deferral.

References

Parkkali T, Volin L, Sirén MK, Ruutu T. Acute iritis induced by granulocyte colony-stimulating factor used for mobilization in a volunteer unrelated peripheral blood progenitor cell donor. Bone Marrow Transplant. 1996 Mar;17(3):433-4. [1]

Tsuchiyama J, Imajo K, Sakaguchi N, Yoshino T, Suzaki N, Kondo E, Kawata N, Okada K, Maeda T, Tomiyama Y, Tsubota T Recurrent idiopathic iridocyclitis after autologous peripheral blood stem-cell transplantation followed by G-CSF administration for acute lymphoblastic leukemia. Ann Hematol. 2000 May;79(5):269-71. [2]

Faucher B, Garcia-Meric P, Franck J, Minodier P, Francois P, Gonnet S, L'ollivier C, Piarroux R. Long-term ocular outcome in congenital toxoplasmosis: a prospective cohort of treated children. J Infect. 2012 Jan;64(1):104-9. doi: 10.1016/j.jinf.2011.10.008. Epub 2011 Oct 24. [3]

Condition

Injection of any drug or other substance not prescribed by a qualified physician or other healthcare professional. This encompasses, for example, drugs of addiction such as heroin, and use of non-prescribed injected anabolic steroids.

Individual at risk

Recipient

Guidance at RECRUITMENT for adult volunteer donor and maternal donor (cord blood donation)

UNACCEPTABLE if injected drugs of addiction within the previous five years

UNACCEPTABLE if injected other non-prescription drugs, such as anabolic steroids, within the previous six months

Guidance at CT/WORK-UP

UNACCEPTABLE if injected drugs of addiction within the previous five years

If donor has injected androgenic steroid, or other non-addictive medications, then they may proceed at the discretion of the requesting transplant centre.

Justification for guidance

Use of non-prescribed injected drugs of addiction is associated with a considerably higher risk of transmission of blood borne infectious diseases.

Although case reports of transmission of hepatitis C have been reported in users of androgenic steroids have been reported, the exposure risk remains very low and such donors may proceed at the discretion of the requesting transplant centre.

References

Elghouzzi MH, Bouchardeau F, Pillonel J, Boiret E, Tirtaine C, Barlet V et al. Hepatitis C virus: routes of infection and genotypes in a cohort of anti-HCV-positive French blood donors. Vox Sang 2000; 79(3): 138-44.

Aitken C, Delalande C, Stanton K. Pumping iron, risking infection? Exposure to hepatitis C, hepatitis B and HIV among anabolic-androgenic steroid injectors in Victoria, Australia. Drug Alcohol Depend 2002; 65(3): 303-8.

Midgley SJ, Heather N, Best D, Henderson D, McCarthy S, Davies JB. Risk behaviours for HIV and hepatitis infection among anabolic-androgenic steroid users. AIDS Care 2000; 12(2): 163-70.

Rich JD, Dickinson BP, Merriman NA, Flanigan TP. Hepatitis C virus infection related to anabolic-androgenic steroid injection in a recreational weight lifter. Am J Gastroenterol 1998; 93(9): 1598.

Condition

Accidental penetration of the skin, or splash in the eye, with an object potentially contaminated with human bodily fluids.

Individual at risk

Recipient

Guidance at RECRUITMENT for adult volunteer donor and maternal donor (cord blood donation)

ACCEPTABLE

Guidance at CT/WORK-UP

Acceptable if four months have passed since injury and validated nucleic acid testing (NAT) is used for hepatitis B and C.

Unacceptable if needle/instrument may have been contaminated with abnormal prion protein.

This deferral period may be shortened at the discretion of the requesting transplant centre.

Justification for guidance

There is a risk of transmission of blood-borne viruses through an accidental innoculation injury if the offending instrument is contaminated with bodily fluids.

References

Scaggiante R, Chemello L, Rinaldi R, Bartolucci GB, Trevisan A. Acute hepatitis C virus infection in a nurse trainee following a needlestick injury. World J Gastroenterol 2013; 19(4): 581-5.

Res S, Bowden FJ. Acute hepatitis B infection following a community-acquired needlestick injury. J Infect 2011; 62(6): 487-9.

Morand P, Dutertre N, Minazzi H, Burnichon J, Pernollet M, Baud M et al. Lack of seroconversion in a health care worker after polymerase chain reaction-documented acute hepatitis C resulting from a needlestick injury. Clin Infect Dis 2001; 33(5): 727-9.

Wormser GP. Estimation of risk of transmission of non-A, non-B hepatitis by needlestick injury. Gastroenterology 1991; 101(3): 871-2.

Basic information

A parasite infection of red blood cells, transmitted to humans by a particular type of mosquito ( Anopheles ) that is prevalent in rural tropical and sub-tropical settings.

Types

There are five known species of Plasmodium parasites that infect humans:

falciparum
vivax
ovale
malariae
knowlesi

Individual at risk

Recipient

Risk factors for malaria in healthy donors

Recent travel – i.e. a history of visiting a malaria risk area within a defined time period prior to assessment.
- Most guidelines define a time period of 12 months or less, though a period of up to 3 years may be utilised in order to cover an extended risk of relapsing vivax infection and/or to comply with European guidelines relating to unexplained fevers occurring after “tropical” travel.
Past infection – i.e. a known history of previous malaria infection.
- In the context of young volunteer HPC donors, this can be defined simply as any malaria diagnosis at any time of life.
Past residence – i.e. a history of previous residence in a malaria risk area.
- Most commonly defined as a continuous period of 6 months or longer.
- European guidelines attribute risk to residence at any stage of life, but the highest risk occurs with repeated exposures from early childhood.

A donor who has recently travelled to a malaria risk area can develop symptomless malaria infection in situations like relapsing P. vivax infection and incomplete treatment with prophylactic anti-malarial medications.

A donor with a previous history of malaria infection can pose a risk to HPC recipients through semi-immunity or partial immunity to malaria – particularly if infected during childhood, which can occur without clear symptoms or a specific diagnosis.

A semi-immune individual remains susceptible to new malaria infection, but will be less likely to develop severe illness. In some cases, a semi-immune individual can develop prolonged symptomless infection after re-exposure to malaria, posing a risk to recipients if they donate blood or HPCs.

Malaria antibody testing, where available, can be useful in evaluating the risk of symptomless malaria in a healthy donor with a history of potential malaria exposure – especially the risk associated with malaria semi-immunity, which accounts for the overwhelming majority of cases of reported and potential transmission of malaria via blood products.

Note that regulations such as the European Directive for blood and tissues set a 4-month window period for malaria antibody testing, but the true window period is likely to be closer to 2 weeks.

Guidance at RECRUITMENT

Recent travel:
- Any travel to a malaria risk area within the past 12 months.
- ACCEPTABLE.
Past infection:
- A known history of malaria infection at any time of life.
- ACCEPTABLE if the donor has fully recovered from malaria for a period of at least 12 months.
- Registries located in countries with endemic malaria risk may wish to consider a shorter recovery period – e.g. ACCEPTABLE as long as the donor has fully recovered.
Past residence:
- Previous residence in a malaria risk area or areas for a continuous period of 6 months or longer, at any time of life.
- ACCEPTABLE

Guidance at CT/WORK-UP

Recent travel:
- Any travel to a malaria risk area within the past 12 months.
- ACCEPTABLE, but disclose risk to the transplant centre.
- Registries located in a country with endemic malaria risk may wish to omit this question, or modify it to capture travel to higher-risk regions within the same country or other countries.
- Malaria antibody testing, where available, can be useful to evaluate the possibility of symptomless infection following recent risk travel. Note that there have been case reports of relapsing vivax malaria in blood donors where antibody screening has been negative during an asymptomatic interval.
Past infection:
- A known history of malaria infection at any time of life.
- ACCEPTABLE if the donor has fully recovered from malaria for a period of at least 12 months. Advise the transplant centre of the potential risk of semi-immunity – particularly if there has been subsequent or ongoing geographical exposure to malaria following recovery.
- If the donor/registry is located in a country with endemic malaria risk and/or there is no alternative donor available, a shorter recovery period may be considered.
- Malaria antibody testing, where available, is useful for detecting semi-immunity. In a donor with a past history of infection and subsequent/ongoing geographical exposure, the presence or absence of malaria antibodies is a useful indicator of the possibility of prolonged symptomless infection.
- A positive antibody result should be further evaluated by testing for the presence of current infection – e.g. malaria PCR or antigen testing.
Past residence:
- Previous residence in a malaria risk area or areas for a continuous period of 6 months or longer, at any time of life.
- ACCEPTABLE, but disclose risk to the transplant centre.
- If the donor remains currently resident in a country with endemic malaria risk, further evaluation of the donor’s individual risk is recommended because the geographic distribution of malaria risk is uneven within most endemic countries, while the likelihood of semi-immunity is increased by childhood and/or repeated exposure.
- Malaria antibody testing, where available, is useful for detecting semi-immunity. In a donor with a history of past residence in a malaria risk area and subsequent/ongoing geographical exposure, the presence or absence of malaria antibodies is a useful indicator of the possibility of prolonged symptomless infection.
- A positive antibody result should be further evaluated by testing for the presence of current infection – e.g. malaria PCR or antigen testing.

References

Kitchen AD, Barbara JA, Hewitt PE. Documented cases of post-transfusion malaria occurring in England: a review in relation to current and proposed donor-selection guidelines. Vox Sanguinis. 2005;89(2):77-80.

Seed CR, Cheng A, Davis TME, Bolton WV, Keller AJ, Kitchen A and Cobain TJ. The efficacy of a malarial antibody enzyme immunoassay for establishing the reinstatement status of blood donors potentially exposed to malaria. Vox Sang 2005; 88:98-106.

Doolan DL, Dobaño C, Baird JK. Acquired immunity to malaria. Clinical microbiology reviews. 2009;22(1):13-36, Table of Contents.

Reesink HW, Panzer S, Wendel S, Levi JE, Ullum H, Ekblom-Kulberg S, Seifried E, Schmidt M, Shinar E, Prati D, Berzuini A, Ghosh S, Flesland O, Jeansson S, Zhiburt E, Piron M, Sauleda S, Ekermo B, Eglin R, Kitchen A, Dodd RY, Leiby DA, Katz LM and Kleinman. The use of malaria antibody tests in the prevention of transfusion-transmitted malaria. Vox Sang 2010; 98 (3 Pt 2):468-478.

Seed CR, Coughlin JT, Pickworth AM, Harley RJ and Keller AJ. Relapsing vivax malaria despite chemoprophylaxis in two blood donors who had travelled to Papua New Guinea. Med J Aust 2010; 192 (8): 471-473.

Guide to the Preparation, Use and Quality Assurance of Blood Components. European Committee (Partial Agreement) on Blood Transfusion (CD-P-TS), Council of Europe. 16th Edition, 2011.

Kitchen AD, Chiodini PL, Tossell J. Detection of malarial DNA in blood donors--evidence of persistent infection. Vox Sang. 2014;107(2):123-131.

Verra F, Angheben A, Martello E, Giorli G, Perandin F, Bisoffi Z. A systematic review of transfusion-transmitted malaria in non-endemic areas. Malar J. 2018;17(1):36.

O'Brien SF, Ward S, Gallian P, et al. Malaria blood safety policy in five non-endemic countries: a retrospective comparison through the lens of the ABO risk-based decision-making framework. Blood Transfus. 2019;17(2):94-102.

U.S. Department of Health and Human Services FaDA. Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria. In: Research CfBEa, ed. Maryland: Food and Drug Administration; 2020.

Condition

Includes all haematological and non-haematological malignancies, but excludes benign tumours.

Individual at risk

Recipient

Guidance at RECRUITMENT for adult volunteer donor and maternal donor (cord blood donation)

UNACCEPTABLE, except completely treated basal cell carcinoma of the skin and cured in-situ carcinoma (see below).

Guidance at CT/WORK-UP

UNACCEPTABLE, but see below.

Donors with malignancy or with a history of malignancy must not donate.

There are two exceptions from this:

1. Cured carcinoma in-situ. In the EU, legislation limits this category to cervical carcinoma in-situ, whereas in other countries cured localized squamous cell carcinoma of the skin cancer, breast cancer in-situ and bladder cancer in-situ might also be acceptable.

2. Successfully and completely treated basal cell carcinoma

Women with known positivity for BRCA1 or 2 but no history of cancer are acceptable as donors. All such women should have a breast examination performed at work-up.

In the above cases, these conditions must always be communicated to the requesting transplant centre.

Justification for guidance

There is a risk of transmission of malignancy to the recipient.

Melanoma in-situ found in younger people, typical of the age of donors, are uncommon but have a reported recurrence rate of 5%. Such patients are at a higher risk of developing melanoma in other locations. In addition, melanoma has been proven to be transmissible by organ transplantation.

References

Gandhi MJ, Strong DM. Donor derived malignancy following transplantation: a review. Cell Tissue Bank 2007; 8(4): 267-86.

Otero L, de Souza DC, de Cassia Tavares R, Gomes BE, Padilha TF, Bouzas LF et al. Monosomy 7 in donor cell-derived leukemia after bone marrow transplantation for severe aplastic anemia: Report of a new case and review of the literature. Genet Mol Biol 2012; 35(4): 734-6.

Browne PV, Lawler M, Humphries P, McCann SR. Donor-cell leukemia after bone marrow transplantation for severe aplastic anemia. N Engl J Med 1991; 325(10): 710-3.

Condition

Mild, occasional episodes of back pain related to exertion (incl sciatica). Minimal impact on activities of daily living and occasional use of medication

Individual at risk

Donor

Guidance at RECRUITMENT for adult volunteer donor (NA for maternal donor (cord blood donation))

ACCEPT

Guidance at CT/WORK-UP

ACCEPT, CONSIDER PBSC ONLY

Justification for guidance

Pain or underlying condition may be aggravated or triggered by collection, and particularly bone marrow collection. At CT/work-up stage evaluate for on-going symptoms. May be considered for PBSC only on a case-by-case basis. Inform transplant centre if medically suitable for PBSC only.

Condition

Monoclonal gammopathy of undetermined significance (MGUS, unknown or uncertain may be substituted for undetermined), formerly benign monoclonal gammopathy, is a condition in which an abnormal immunoglobin protein (known as a paraprotein) is found in the blood during standard laboratory blood tests for which there is no diagnosis. The levels of antibody are lower than in Multiple Myeloma or other malignancies that are associated with monoclonal gammopathy. Usually there are no signs or symptoms. The estimated risk of transformation into a malignancy varies from 2.1% to less than 0.3% per year and depends on number of years after diagnosis, subtype of MGUS and serum level of the protein.

Guidance at RECRUITMENT

UNACCEPTABLE

Guidance at CT/WORK-UP

UNACCEPTABLE

Justification for guidance

Because of the risk of transformation into a hematologic malignancy there is a risk for both the donor and recipient.

References

Donor suitability working group WMDA meeting Munich 2018.

Ronald S. Go and S. Vincent Rajkumar; How I manage monoclonal gammopathy of undetermined significance. Blood. 2018;131(2):163-173

Condition

Myalgic encephalomyelitis (ME)/chronic fatigue syndrome

A significantly debilitating medical disorder or group of disorders generally defined by persistent fatigue accompanied by other specific symptoms for a minimum of six months in adults (and 3 months in children/adolescents), not due to ongoing exertion, not substantially relieved by rest, and not caused by other medical conditions. Symptoms affect several body systems and may include post-exertion malaise lasting more than 24 hours, unrefreshing sleep, significant impairment of short-term memory or concentration, muscle pain, pain in the joints without swelling or redness, headaches of a new type, pattern, or severity, tender lymph nodes in the neck or armpit, a sore throat that is frequent or recurring. Several pathophysiologic mechanisms have been postulated such as (acute) viral illness, psychiatric disorders, abnormalities in brain structure and function, neuroendocrine responses, sleep architecture and immune function. Environmental as well as genetic factors have been suspected to play a role. Despite all these studies there is not a definite etiology of this disease that is generally accepted.

Individual at risk

Donor / recipient

Guidance at RECRUITMENT for adult volunteer donor and maternal donor (cord blood donation)

UNACCEPTABLE

Guidance at CT/WORK-UP

DEFER PERMANENTLY

Justification for guidance

Due to the fact that the disease does not have a well defined etiology, both donor and recipient may be at risk during or after stem cell donation. Several national blood banks have similar guidance.

References

Afari N, Buchwald D. Chronic fatigue syndrome: a review. Am J Psychiatry 2003; 160(2): 221-36.

CFS Case Definition. Centre for Disease Control May 14th 2012, http://www.cdc.gov/cfs/case-definition/index.html, retrieved February 2nd 2013.

Condition
Individual at risk
Guidance at RECRUITMENT
Guidance at CT/WORK-UP
Justification for guidance
References

Condition

Individual at risk

Guidance at RECRUITMENT

Guidance at CT/WORK-UP

Accept for PBSC donation, if no cardiorespiratory abnormalities
Accept for BM donation, subject to anaesthetic assessment at work-up. Document any additional risk factors for cardiovascular disease. Anaesthetist for BM procedure must be made aware of condition and pre-anaesthetic assessment at work-up.

Justification for guidance

References

Condition

An abnormal reduction in bone mineral density associated with an increased risk of fractures. The most common aetiology relates to post-menopausal reductions in circulating oestrogen, and as such this condition far more commonly affects females.

Individual at risk

Donor

Guidance at RECRUITMENT

Establish cause, and if not otherwise excluded may join.

Guidance at CT/WORK-UP

Establish cause, and if not otherwise excluded may donate by PBSC only. Inform requesting transplant centre that donor is PBSC only.

Hormone replacement therapy for post-menopausal females is usually not derived from human tissues, and therefore acceptable in this context.

Justification for guidance

Shearing stresses applied to the pelvis and lower spine during bone marrow harvest may be a particular risk in donors with osteoporosis.

References

Gladden K, Spill GR. Iliac fracture after a bone marrow biopsy. Pm R 2011; 3(12): 1150-2.

Condition

Household contact of person with hepatitis B infection

Individual at risk

Recipient

Guidance at RECRUITMENT for adult volunteer donor and maternal donor (cord blood donation)

Acceptable if donor can prove to be hepatitis B surface antibody positive.

Guidance at CT/WORK-UP

Donor may be accepted only if:

Donor is negative for all markers

OR

Donor is hep B core antibody positive, heb B surface antigen negative and hep B surface antibody has been documented to be more than 100 iu/l at some time.

Justification for GUIDANCE

Hepatitis B infection can be passed to close household contacts and might be passed on to recipient by transplant of stem cells.

Notes

This advice is a requirement of the EU Tissues and Cells Directive.

Condition

Pneumothorax is a collection of air or gas in the chest or pleural space that causes part or all of a lung to collapse. A primary (simple) pneumothorax occurs spontaneously, often in healthy, tall, slender young men (20-40 yrs.). However, the pathophysiology is uncertain. There is a 30-50% risk for recurrence of the condition. The condition is considered benign.

A secondary (complicated) spontaneous pneumothorax can occur in patients with underlying pulmonary disease (e.g. COPD, cystic fibrosis, pulmonary infection) is more serious and often life threatening.

A traumatic (tension) pneumothorax may follow a chest trauma, requiring immediate treatment by tube thoracostomy.

Individual at risk

DONOR

Guidance at RECRUITMENT

UNACCEPTABLE in case of repeated primary pneumothorax or a secondary pneumothorax in medical history.

Evaluate donor’s current condition and underlying condition after a (single time) primary pneumothorax or traumatic pneumothorax. ACCEPT if appropriate.

Guidance at CT/WORK-UP

PERMANENTLY DEFER in case of repeated primary pneumothorax or a secondary pneumothorax in medical history.

Evaluate donor’s current condition and underlying condition after a (single time) primary pneumothorax or traumatic pneumothorax. ACCEPT if appropriate.

Justification for guidance

A history of pneumothorax may confer an additional risk for a donor undergoing general anaesthetic or requiring central line insertion.

Pregnancy

Individual at risk

Donor

Guidance at RECRUITMENT for adult volunteer donor (NA for maternal donor (cord blood donation))

ACCEPTABLE. It is very unlikely that a donor who is pregnant at recruitment will be called to donate within the first year of joining the register.

Guidance at CT/WORK-UP

QUALIFIED, see below

Guidance

Unacceptable if:

Currently pregnant;
Less than one week has passed for every completed week of a recent pregnancy
Less than three months have passed since a first trimester
The pregnancy resulted in a malignant hydatidiform mole
The pregnancy resulted in a non-malignant hydatidiform mole and treatment and follow-up is ongoing

Breastfeeding

Individual at Risk

Donor (infant)

Guidance at RECRUITMENT

ACCEPTABLE

Guidance at CT / WORK-UP

QUALIFIED, if the donor is sufficiently informed about and accepts the fact that there are limited data on safety or is willing to interrupt breastfeeding (and throw away any expressed milk, “pump and dump”) during mobilization and for three days after PBSC and for at least 24 hours after Bone Marrow Collection (discuss case per case with the attending anesthesiologist).

Justification for Guidance

In donors who breastfeed and are qualified to donate (taking the recovery period after pregnancy into consideration) the concern is that drugs used in the donation procedure may be ingested by and harmful for the infant. In line with this, several donor suitability guidance documents consider uninterruptible breastfeeding a contra-indication for PBSC and ask the donor if she is willing to interrupt breastfeeding during mobilization and for a couple of days after donation.

However, G-CSF is a normal component of breast milk. Limited research shows that filgrastim and lenograstim are poorly excreted into breastmilk^1-3 and are undetectable by 3 days after an injection.⁴

Evidence also suggests that G-CSF given to neonates orally is not absorbed in significant quantities.⁵ In a single-center crossover study in which 22 infants received 1 dose of rhG-CSF (100 microg/kg) (10 times the subcutaneous dose) orally, no side-effects, safety issues or significant changes in plasma G-CSF concentration were observed.⁵ In a placebo controlled study G-CSF was safely given to 8 infants suffering from necrotizing enterocolitis.⁶ These studies suggest that G-CSF mainly has a local effect on the GI tract and not systemically.

Relevant data is reviewed and updated in Drugs and Lactation Database (LactMed).⁷

Based on these data the Specialist Pharmacy Service in the UK states that filgrastim (and per expert advice) also lenograstim can be used during lactation.⁸

The recommendation is to inform the donor about the available data and to leave the decision to continue or interrupt breastfeeding to her.

References

1.Pessach I, Shimoni A, Nagler A. Granulocyte-colony stimulating factor for hematopoietic stem cell donation from healthy female donors during pregnancy and lactation: what do we know? Hum Reprod Update. 2013;19:259–67. [PubMed]

2.Shibata H, Yamane T, Aoyama Y, et al. Excretion of granulocyte colony-stimulating factor into human breast milk. Acta Haematol. 2003;110:200–1. [PubMed]

3.Nelson RC. Granulocyte colony-stimulating factor (G-CSF) in breastmilk of a nursing donor during hematopoietic progenitor cells (HPC) mobilization. Transfusion 2018;58 (Suppl S2):169A. Abstract. doi:10.1111/trf.14903. [CrossRef]

4.Kaida K, Ikegame K, Fujioka T, et al. Kinetics of granulocyte colony-stimulating factor in the human milk of a nursing donor receiving treatment for mobilization of the peripheral blood stem cells. Acta Haematol. 2007;118:176–7. [PubMed]

5.Calhoun DA, Maheshwari A, Christensen RD. Recombinant granulocyte colony-stimulating factor administered enterally to neonates is not absorbed. Pediatrics. 2003;112:421–3. [PubMed]

6.Canpolat FE, Yurdakok M, Korkmaz A, et al. Enteral granulocyte colony-stimulating factor for the treatment of mild (stage I) necrotizing enterocolitis: a placebo-controlled pilot study. J Pediatr Surg. 2006;41:1134–8. [PubMed]

Drugs and Lactation Database (LactMed). https://www.ncbi.nlm.nih.gov/books/NBK501373/
Specialist Pharmacy Service. https://www.sps.nhs.uk/medicines/filgrastim/#:~:text=filgrastim

Condition

Sporadic, familial and variant Creutzfeldt-Jakob disease (CJD), Gerstmann-Straussler-Scheinker diseases and fatal familial insomnia.

Individual at risk

Recipient

Guidance at RECRUITMENT for adult volunteer donor and maternal donor (cord blood donation)

Unacceptable if:

1. diagnosed with any form of CJD or other prion-associated disorder.

2. identified as at increased risk of developing a prion-associated disorder. This includes:

a) individuals at familial risk of developing a prion-associated disorder (have had two or more blood relatives develop a prion-associated disorder or have been informed they are at risk following genetic counselling.)

b) individuals who have been told they have been put at increased risk from surgery, transfusion or transplant of tissues and organs.

c) individuals who have been told they may be at increased risk because a recipient of blood or tissues they have donated has developed a prion-related disorder.

d) recipients of dura mater grafts

e) recipients of corneal, scleral or other ocular tissue grafts.

f) recipients of human pituitary derived extracts eg Metrodin, human growth hormone.

Guidance at CT/WORK-UP

List as above.

If the donor is asymptomatic then they may proceed at the discretion of the requesting transplant centre.

Justification for guidance

Prion-associated diseases are transmissible by transfusion of blood and likely to be transmissible by stem cells too.

Renal diseases not transmissible via HCST

Examples:

Congenital malformation
Nephrectomy after injury or dysfunctional kidney (e.g. hydronephrosis from childhood)
Polycystic kidney disease
Nephrotic syndrome

Other conditions:

Nephrolithiasis (kidney stones)
Kidney donation

Individual at risk

Donor

Guidance at RECRUITMENT for adult volunteer donor and maternal donor (cord blood donation)

UNACCEPTABLE if progressive disease and / or global renal function is impaired.

Guidance at CT/WORK-UP

PERMANENT DEFERRAL if progressive disease and / or global renal function substantially impaired.

Otherwise, according to clinical reasoning by the assessing physician, the donor could be eligible, temporarily unavailable or permanently deferred.

Evaluate carefully for absence of inflammatory (autoimmune or infectious) nephropathy. If there is a suspicion of an inflammatory nephropathy, but renal biopsy is not indicated, inform the requesting transplant centre and proceed with bone marrow collection only if requested (see below).

Nephrolithiasis: Assess the type of kidney stones in the available medical history, document the type of kidney stones if this information is available. Accept if fully recovered from acute event.

Justification for guidance

Use of granulocyte colony-stimulating factor has been associated with reports of acute glomerulonephritis, almost all of which have been immune complex associated.

Donors with progressive disease or impaired kidney function may be at increased risk of adverse events associated with either type of donation.

Renal diseases potentially transmissible via HCST

Condition

Chronic infectious or autoimmune diseases, for example:

Tuberculosis
Chronic pyelonephritis
Chronic glomerulonephritis
IgA nephropathy

Individual at risk

Donor / recipient

Guidance at RECRUITMENT for adult volunteer donor and maternal donor (cord blood donation)

IgA nephropathy ACCEPTABLE

Others UNACCEPTABLE

Guidance at CT/WORK-UP

Biopsy/diagnosis confirmed IgA nephropathy ACCEPTABLE for bone marrow only if condition does not impact kidney function. Inform the requesting transplant centre and proceed if requested.

Others UNACCEPTABLE, PERMANENT DEFERRAL

Justification for guidance

Donors with chronic infectious or autoimmune disease may experience exacerbations of their disease as a result of donation. In addition, there is a risk of transmission of infectious agents or autoreactive lymphocytes to the recipient.

References

Batal I, Markowitz G, Wong W, et al. Filgrastim-induced crescentic transformation of recurrent IgG2λ GN. J Am Soc Nephrol. 2016;27(7):1911-1915.
Chandra P, Dahiya S, Sanchez-Petitto G, et al. Acute glomerulonephritis in a hematopoietic blood stem cell donor. Clin Nephrol Case Stud. 2021;9:81-86.
Guffroy B, Ingwiller M, Gavand P, et al. Flare of IGA glomerulonephritis under G-CSF stimulation regimen for autologous stem cell transplantation in systemic sclerosis. Rheum (Oxford). 2020;59(9):e33-e34.
Korman A, Leiba A, Edel Y, et al. G-CSF-induced ANCA associated glomerulonephritis in the presence of silent membranous “full house nephropathy” in an altruistic bone marrow donor. Renal Failure. 2022;44(1):1499-1501.
Nasilowska-Adamska B, Perkowska-Ptasinska A, Tomaszewska A, et al. Acute glomerulonephritis in a donor as a side effect of allogeneic peripheral blood stem cell mobilization with granulocyte colony-stimulating factor. Int J Hematol. 2010;92(5):765-768.

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Donors with severe chronic back pain which impacts on activities of daily living may be considered for PBSC only on a case-by-case basis.

Inform requesting transplant centre if medically suitable for PBSC only

Condition

Severe or Systemic autoimmune disease, including:

Inflammatory bowel disease

Multiple sclerosis (MS)

Systemic lupus erythematosus (SLE)

Inflammatory arthritis (including rheumatoid arthritis)

Scleroderma/CREST

Sarcoidosis

Guillain-Barre syndrome

Wegener granulomatosis

Goodpasture syndrome

Individual at risk

Donor / recipient

Guidance at RECRUITMENT for adult volunteer donor and maternal donor (cord blood donation)

UNACCEPTABLE

Guidance at CT/WORK-UP

QUALIFIED. Donors in remission of the above diseases who have not required systemic therapy for more than one year may be considered for donation on an individual basis, but should not receive granulocyte colony stimulating factor and thus donate by bone marrow only.

Risk of adoptive transfer of disease-causing cells should be discussed with the recipient, and risks of disease activation should be discussed with the donor.

Justification for guidance

Autoimmune disease on this list can be passed by adoptive transfer of t-lymphocytes in experimental animal models, and these diseases are recapitulated in recipient animals. Donor genetic polymorphisms that predispose to inflammatory bowel disease may induce this disease in transplant recipients, and there is clinical evidence of disease transfer in donor:recipient pairs.

Donors with systemic autoimmune/inflammatory disease may be at risk for Macrophage Activation Syndrome upon administration of granulocyte colony stimulating factor.

References

Anderlini P, Przepiorka D, Korbling M, Champlin R. Blood stem cell procurement: donor safety issues. Bone Marrow Transplant 1998; 21 Suppl 3: S35-9.

Bhagat R, Rizzieri DA, Vredenburgh JJ, Chao NJ, Folz RJ. Pulmonary sarcoidosis following stem cell transplantation: is it more than a chance occurrence? Chest 2004; 126(2): 642-4.

Lampeter EF, Homberg M, Quabeck K, Schaefer UW, Wernet P, Bertrams J et al. Transfer of insulin-dependent diabetes between HLA-identical siblings by bone marrow transplantation. Lancet 1993; 341(8855): 1243-4.

Lampeter EF, McCann SR, Kolb H. Transfer of diabetes type 1 by bone-marrow transplantation. Lancet 1998; 351(9102): 568-9.

Marmont AM. Autoimmunity and allogeneic bone marrow transplantation. Bone Marrow Transplant 1992; 9(1): 1-3.

Openshaw H, Stuve O, Antel JP, Nash R, Lund BT, Weiner LP, et al. Multiple sclerosis flares associated with recombinant granulocyte colony-stimulating factor. Neurology 2000;54(11):2147-50.

Snowden JA, Atkinson K, Kearney P, Brooks P, Biggs JC. Allogeneic bone marrow transplantation from a donor with severe active rheumatoid arthritis not resulting in adoptive transfer of disease to recipient. Bone Marrow Transplant 1997; 20(1): 71-3.

Sonwalkar SA, James RM, Ahmad T, Zhang L, Verbeke CS, Barnard DL et al. Fulminant Crohn's colitis after allogeneic stem cell transplantation. Gut 2003; 52(10): 1518-21.

Vialettes B, Maraninchi D. Transfer of insulin-dependent diabetes between HLA-identical siblings by bone marrow transplantation. Lancet 1993; 342(8864): 174.

Waters AH, Metcalfe P, Minchinton RM, Barrett AJ, James DC. Autoimmune thrombocytopenia acquired from allogeneic bone-marrow graft: compensated thrombocytopenia in bone marrow donor and recipient. Lancet 1983; 2(8364): 1430.

Condition

Single organ autoimmune disease, including:

Condition

Single organ autoimmune disease, including:

Coeliac disease (celiac disease, sprue)
Pernicious anaemia
Alopecia areata
Vitiligo

GUIDANCE FOR THYROID DISEASE

Thyroid disease (e.g.Hashimoto throiditis, Graves disease).

Donor must not donate if:

Malignant (cancerous);
Any thyroid disorder under investigation;
Graves disease (hyperthyroidism or thyrotoxicosis) within six months of treatment with radioactive iodine therapy;
Graves disease (hyperthyroidism or thyrotoxicosis) within 2 years of completing anti-thyroid tablet therapy (e.g. carbimazole);
Currently taking beta-blockers;

GUIDANCE FOR PSORIASIS

Psoriasis is a primarily a skin condition caused by an autoimmune process. About one in ten people with psoriasis may develop join problems (psoriatic arthropathy). Sometimes the disease is treated with powerful drugs to suppress the underlying autoimmune process. This may alter the body's defence mechanism to infection. In such cases the donations should not be taken.

Donor must not donate if:

has ever taken Etretinate (Tigason)
less than 24 months from the last dose of Acitretin (Neotigason)
generalized or server
associated with arthropathy
there is a secondary infection

If mild and only topical treatment, accept.

Justification for guidance

Adoptive transfer of these autoimmune diseases has been documented following allogeneic transplant. Because these diseases are not usually life threatening, the recipient and the transplant physician should weigh the risk/benefits of using the specific donor on an individual basis.

References

Aldouri MA, Ruggier R, Epstein O, Prentice HG. Adoptive transfer of hyperthyroidism and autoimmune thyroiditis following allogeneic bone marrow transplantation for chronic myeloid leukaemia. Br J Haematol 1990; 74(1): 118-9.

Berisso GA, van Lint MT, Bacigalupo A, Marmont AM. Adoptive autoimmune hyperthyroidism following allogeneic stem cell transplantation from an HLA-identical sibling with Graves' disease. Bone Marrow Transplant 1999; 23(10): 1091-2.

Campbell-Fontaine A, Coad JE, Kovach R, Ericson SG. Adoptive transfer of vitiligo after allogeneic peripheral blood stem cell transplant. Bone Marrow Transplant 2005; 36(8): 745-6.

Gardembas-Pain M, Ifrah N, Foussard C, Boasson M, Saint Andre JP, Verret JL. Psoriasis after allogeneic bone marrow transplantation. Arch Dermatol 1990; 126(11): 1523.

Holland FJ, McConnon JK, Volpe R, Saunders EF. Concordant Graves' disease after bone marrow transplantation: implications for pathogenesis. J Clin Endocrinol Metab 1991; 72(4): 837-40.

Karthaus M, Gabrysiak T, Brabant G, Prahst A, Link H, Soudah B et al. Immune thyroiditis after transplantation of allogeneic CD34+ selected peripheral blood cells. Bone Marrow Transplant 1997; 20(8): 697-9.

Kishimoto Y, Yamamoto Y, Ito T, Matsumoto N, Ichiyoshi H, Katsurada T et al. Transfer of autoimmune thyroiditis and resolution of palmoplantar pustular psoriasis following allogeneic bone marrow transplantation. Bone Marrow Transplant 1997; 19(10): 1041-3.

Temporary deferral for 4 months due to potential transmission of infectious diseases.

The transplant centre should be informed and this time period may be shortened at their discretion.

Justification for guidance

Healing progression and risk for infections (local wound infections as well as systemic infections like hepatitis or tetanus) can only be assessed AFTER a reasonable time lag.

References

Investigation of viral hepatitis infections possibly associated with health-care delivery--New York City, 2008-2011. MMWR Morb Mortal Wkly Rep 2012; 61(19): 333-8.

Wu H, Shen B. Health care-associated transmission of hepatitis B and C viruses in endoscopy units. Clin Liver Dis 2010; 14(1): 61-8; viii.

Gutelius B, Perz JF, Parker MM, Hallack R, Stricof R, Clement EJ et al. Multiple clusters of hepatitis virus infections associated with anesthesia for outpatient endoscopy procedures. Gastroenterology 2010; 139(1): 163-70.

Gonzalez-Candelas F, Guiral S, Carbo R, Valero A, Vanaclocha H, Gonzalez F et al. Patient-to-patient transmission of hepatitis C virus (HCV) during colonoscopy diagnosis. Virol J 2010; 7: 217.

Toda T, Mitsui T, Tsukamoto Y, Ebara T, Masuko K, Takahashi M et al. No evidence for patient-to-patient transmission of hepatitis C virus during upper gastrointestinal endoscopy: molecular studies on three acute hepatitis C patients. Dig Endosc 2009; 21(3): 147-53.

Dore GJ, Haber PS. Tell me it ain't so: patient-to-patient transmission of hepatitis C in an endoscopy clinic. Hepatology 2008; 48(4): 1333-5.

Boustiere C, Napoleon B, Delasalle P, Coulom P. Digestive endoscopies are not a risk factor for transmission of virus C. J Viral Hepat 2008; 15(2): 155.

Nelson DB. Hepatitis C virus cross-infection during endoscopy: is it the "tip of the iceberg" or the absence of ice? Gastrointest Endosc 2007; 65(4): 589-91.

Mikhail NN, Lewis DL, Omar N, Taha H, El-Badawy A, Abdel-Mawgoud N et al. Prospective study of cross-infection from upper-GI endoscopy in a hepatitis C-prevalent population. Gastrointest Endosc 2007; 65(4): 584-8.

Vanhems P, Gayet-Ageron A, Ponchon T, Bernet C, Chayvialle JA, Chemorin C et al. Follow-up and management of patients exposed to a flawed automated endoscope washer-disinfector in a digestive diseases unit. Infect Control Hosp Epidemiol 2006; 27(1): 89-92.

Morris J, Duckworth GJ, Ridgway GL. Gastrointestinal endoscopy decontamination failure and the risk of transmission of blood-borne viruses: a review. J Hosp Infect 2006; 63(1): 1-13.

Nelson DB. What is the risk of transmission of hepatitis C virus during digestive endoscopy? Nat Clin Pract Gastroenterol Hepatol 2005; 2(12): 560-1.

Notes

Registries should ensure compliance local/national legislation, which may stipulate a different minimum deferral period following surgery and endoscopy.

Condition

Syphilis

Individual at risk

Donor / Recipient

Guidance at RECRUITMENT for adult volunteer donor

Accept

Guidance at Recruitment and Testing of maternal donor (cord blood donation) if currently pregnant and intention to donate

Accept if negative or appropriate treatment depending on test results.

Guidance at CT/WORK-UP

Accept if:

Past false-positive screening test –OR-

Successfully completed treatment. Treatment protocol should be according to international standard of treatment ¹. Consult with Transplant Center.

Justification for guidance

Curable infection when properly treated

References

STI Treatment Guidelines 2021 - Centers for Disease Control Last reviewed May 2023. - https://www.cdc.gov/std/treatment-guidelines/p-and-s-syphilis.htm

WHO (World Health Organization) 2016 Guidelines/Syphilis - who.int/health-topics/syphilis#tab=tab_3

Notes

Those who acquire syphilis may also be at increased risk of STDs (sexually transmitted diseases).

Medical assessment needed for adequacy of treatment based on disease status, treatment regimen received, and response to treatment by laboratory assays.

Condition

Any acupuncture, body piercing, permanent or semi-permanent make-up or tattoo.

Individual at risk

Recipient

Guidance at RECRUITMENT for adult volunteer donor and maternal donor (cord blood donation)

ACCEPTABLE

Guidance at CT/WORK-UP

ACCEPTABLE at the discretion of the requesting transplant centre, who should be informed where and when the procedure occured.

Nucleic acid testing (NAT) for hepatitis B, C and HIV are recommended.

Justification for guidance

There is a risk of transmission of blood-borne viruses, particularly hepatitis B and C, through the use of inadequately sterilised equipment used for tattoo, acupuncture and body piercings. A 4 month deferral is recommended from the date of the procedure, but this may be reduced by the transplant centre if it is thought that the risk of acquiring an infectious disease is outweighed by the risk of delaying transplantation.

4 months allows for the 'window period' between disease exposure and the earliest the disease may be detected by modern nucleic acid testing (NAT) assays.

References

Silverman AL, Sekhon JS, Saginaw SJ, Wiedbrauk D, Balasubramaniam M, Gordon SC. Tattoo application is not associated with an increased risk for chronic viral hepatitis. Am J Gastroenterol 2000; 95(5): 1312-5.

Rosario Pac M, Arnedo A, Montaner MD, Prieto P, Garcia J, Izuel M et al. [Epidemic outbreak of hepatitis B from the tattoo in gypsy families]. Rev Esp Salud Publica 1996; 70(1): 63-9.

Davis AR. Tattoo parlours and hepatitis C virus infection. Med J Aust 1995; 163(10): 556-7.

Ernst E, Sherman KJ. Is acupuncture a risk factor for hepatitis? Systematic review of epidemiological studies. J Gastroenterol Hepatol 2003; 18(11): 1231-6.

Walsh B, Maguire H, Carrington D. Outbreak of hepatitis B in an acupuncture clinic. Commun Dis Public Health 1999; 2(2): 137-40.

Arya SC. Acupuncture in epidemic HBV hepatitis: other ritual surgical procedures in Africa as well. Hepatology 1989; 9(3): 511.

Kent GP, Brondum J, Keenlyside RA, LaFazia LM, Scott HD. A large outbreak of acupuncture-associated hepatitis B. Am J Epidemiol 1988; 127(3): 591-8.

Stryker WS, Gunn RA, Francis DP. Outbreak of hepatitis B associated with acupuncture. J Fam Pract 1986; 22(2): 155-8.

Hayes MO, Harkness GA. Body piercing as a risk factor for viral hepatitis: an integrative research review. Am J Infect Control 2001; 29(4): 271-4.

Condition

Thrombosis and thrombophilia

Name of conditions

(History of) Thrombosis, examples of conditions:

Deep Venous Thrombosis (DVT)

Pulmonary Embolism (PE)

Portal Vein Thrombosis

Renal Vein Thrombosis

Jugular Vein Thrombosis

Budd Chiari Syndrome

Paget-Schroetter disease

Cerebral venous sinus thrombosis

Arterial thrombosis (causing infarction)

Thrombophilia: a congenital or acquired tendency to (abnormal) formation of clots in veins and arteries, examples of conditions:

Factor V Leiden

Factor II mutation

Antithrombin III deficieny

Protein C deficiency

Protein S deficiency

(History of) Antiphosholipid syndrome

Pregnancy

Paroxysmal Nocturnal Hemoglobinuria (PNH)

Several other hematologic diseases such as sickle cell disease and myeloproliferative disorders

Individual at risk

Donor and (in case of genetic disorder/ predisposition) recipient

Guidance at RECRUITMENT for adult volunteer donor (NA for maternal donor (cord blood donation))

ACCEPTABLE if single provoked deep vein thrombosis in the leg (e.g. secondary to trauma, pregnancy or immobilisation), the donor has been fully evaluated to exclude an underlying pathology (including inherited thrombophilia), and the donor has completed the required course of anticoagulant therapy

Otherwise DEFER.

Guidance at CT/WORK-UP

Donors with any history of a single provoked deep vein thrombosis should be carefully reviewed on a case-by-case basis before deciding to proceed with donation.

Donors with any other form of thrombosis or recurrent thrombosis should not donate.

Justification for guidance

The impact of rhG-CSF treatment on the coagulation system has been evaluated in detail. Falanga et al. reported an impact of rhG-CSF on hemostasis in normal donors. They showed an increase in plasma markers of endothelial activation (thrombomodulin and von Willebrand factor antigens) and blood coagulation activation [F1þ2, thrombiantithrombin III (TAT) complex, D-dimer], as well as endotoxin-induced mononuclear cell procoagulant activity. These changes were largely resolved one week after stopping treatment. Topcuoglu et al. reported similar findings. Leblanc et al. found increased levels of factor VIII:C and thrombin generation in normal donors after rhG-CSF administration. Sohngen et al. detected increased factor VIII and fibrinogen levels, while protein C and protein S activities were reduced.

These data suggest that rhG-CSF may induce a transient prothrombotic or hypercoagulable state in donors. Surgery (in bone marrow donation) is a well-known risk factor for thrombosis. A publication by Halter et al. in 2009 reported of several severe events and one death as a consequence of thombotic events in (related) donors donating bone marrow as well as PBSC.

This conclusion has lead to a generally accepted policy to defer donors with (risk factors or a predisposition to) thrombotic events. In publications of registries using this policy no thrombotic events in healthy donors were described (Pulsipher et al).

References

Anderlini P. Effects and safety of granulocyte colony-stimulating factor in healthy volunteers. Current Opinion in Hematology 2009, 16:35–40

LeBlanc R, Roy J, Demers C, et al. A prospective study of G-CSF effects on hemostasis in allogeneic blood stem cell donors. Bone Marrow Transpl 1999; 23:991–996.

Falanga A, Marchetti M, Evangelista V, et al. Neutrophil activation and hemostatic changes in healthy donors receiving granulocyte colony-stimulating factor. Blood 1999; 93:2506–2514.

Topcuoglu P, Arat M, Dalva K, et al. Administration of granulocyte-colony stimulating factor for allogeneic hematopoietic cell collection may induce the tissue factor-dependent pathway in healthy donors. Bone Marrow Transp 2004; 33:171–176.

Sohngen D, Wienen S, Siebler M, et al. Analysis of rhG-CSF-effects on platelets by in vitro bleeding test and transcranial Doppler ultrasound examination. Bone Marrow Transpl 1998; 22:1087–1090.

Halter J, Kodera Y, Ispizua AU, et al. Severe events in donors after allogeneic hematopoietic stem cell donation. Haematologica 2009; 94(1): 94-101.

Pulsipher MA, Chitphakdithai P, Miller JP, et al. Adverse events among 2408 unrelated donors of peripheral blood stem cells: results of a prospective trial from the National Marrow Donor Program. 2009 113: 3604-3611.

Notes

There was some disagreement within the review committee regarding the acceptability of donors who have had a single episode of provoked DVT.

Condition

Toxoplasmosis is a parasitic disease with worldwide distribution. It is caused by the protozoan, Toxoplasma gondii. Though the majority of primary toxoplasmosis infections are asymptomatic, severe cases can present as acute systemic infections [1]. Recently acquired toxoplasmosis or reactivated infections can also present as ocular disease (i.e. posterior uveitis). Immunocompromised individuals are at higher risk for reactivation of a latent infection. Thus, it is more common for reactivation of toxoplasmosis in a seropositive recipient than a donor-transmitted infection [2].

Individual at risk

Recipient

Guidance at RECRUITMENT

ACCEPTABLE if entirely free of symptoms. Defer for donor safety if chronic infection or if clinical manifestation includes ocular disease (i.e. posterior uveitis).

Guidance at CT

ACCEPTABLE if entirely free of symptoms. Defer for donor safety if chronic infection or if clinical manifestation includes ocular disease (i.e. posterior uveitis).

Guidance at WORK-UP

Recommended work-up testing

In countries where all donors must be tested for toxoplasmosis, it is recommended to follow local guidelines / regulation.

Toxoplasmosis-IgM and IgG

Testing outcomes and recommendations

1) Toxoplasmosis IgM = negative AND Toxoplasmosis IgG = positive or negative

Donor can be cleared

2) Toxoplasmosis IgM = positive AND Toxoplasmosis IgG = positive

Avidity testing should be performed to measure the binding strength of specific antibodies to toxoplasmosis antigens. This allows estimation of the time point of primary infection as well as to distinguish between acute and chronic infection.

Toxoplasmosis NAT-testing (PCR) from donor peripheral blood is not relevant, since negative PCR does not exclude relevant infection/parasitemia.

The transplant centre should be informed and clearance or deferral may be appropriate according to avidity test

2) Toxoplasmosis IgM = positive AND Toxoplasmosis IgG = negative

Further laboratory testing is necessary (e.g. Immunoblot/ISAGA) to verify if result is due to acute infection or non-specific binding.

No clearance should be given until clarification is obtained.

Justification for guidance

Toxoplasmosis is a recognised complication of immuno-suppression post-transplant.

References

APA Recommendations of the Center for International Blood and Marrow Transplant Research (CIBMTR®), the National Marrow Donor Program (NMDP), the European Blood and Marrow Transplant Group (EBMT), the American Society of Blood and Marrow Transplantation (ASBMT), the Canadian Blood and Marrow Transplant Group (CBMTG), the Infectious Disease Society of America (IDSA), the Society for Healthcare Epidemiology of America (SHEA), the Association of Medical Microbiology and Infectious Diseases Canada (AMMI), and the Centers for Disease Control and Prevention (CDC), Tomblyn, M., Chiller, T., Einsele, H., Gress, R., Sepkowitz, K., … Boeckh, M. A. (2009). Guidelines for Preventing Infectious Complications among Hematopoietic Cell Transplant Recipients: A Global Perspective. Biology of Blood and Marrow Transplantation : Journal of the American Society for Blood and Marrow Transplantation, 15(10), 1143–1238. doi:10.1016/j.bbmt.2009.06.019 [1]

[1]. Garweg, J.G., Peterson, E. (2020). Toxoplasmosis: Ocular disease. UpToDate. Retrieved October 18, 2023, from https://www.uptodate.com/contents/toxoplasmosis-ocular-disease?search=toxoplasmosis&source=search_result&selectedTitle=5~150&usage_type=default&display_rank=5#references

[2.] Khurana, S., & Batra, N. (2016). Toxoplasmosis in organ transplant recipients: Evaluation, implication, and prevention. Tropical parasitology, 6(2), 123–128. https://doi.org/10.4103/2229-5070.190814

Notes

Page created 7th March 2015

Version	Published	Changed By	Comment
CURRENT (v. 14)	May 22, 2024 19:44	Riny Heijdendael
v. 22	May 22, 2024 19:42	WMDA update system	e4553ff5267525c6e7b9a4253e614087
v. 21	May 22, 2024 19:42	Riny Heijdendael

Go to Page History

Condition

Transfusion with blood components, products and derivatives.

Individual at risk

Recipient

Guidance at RECRUITMENT

ACCEPTABLE, unless:

1. received transfusion in country endemic for malaria or South American trypanosomiasis (Chagas disease). If so, validated tests for malaria antibodies and/or T. cruzi antibody must have been performed (see also Malaria and Chagas disease). If these tests are negative, donor is acceptable.

2. received transfusion within the United Kingdom since 1980. There is a risk of transmission of vCJD.

Autologous transfusion and treatment with human immunoglobulin limited to small quantities as prophylaxis (eg. anti-D, tetanus) are acceptable.

Guidance at CT/WORKUP

As recruitment.

Donors who have received transfusions which place them at risk of Malaria, Chagas disease should have relevant serological assessments performed and may proceed at the discretion of the requesting transplant centre (see also Malaria and Chagas disease).

Donors who have received transfusions within the United Kingdom since 1980 may be proceed at the discretion of the requesting transplant centre.

Nucleic acid testing is recommended for all donors who have received a blood or blood product transfusion within 6 months of donation.

Justification for guidance

Malaria and trypanosomiasis are transmissible by blood transfusion. vCJD appears to be transmissible too and is believed to be caused by BSE which appeared in animal stock in 1980. In view of this, people transfused since 1980 must have a documented risk assessment performed.

References

Peden AH, Head MW, Ritchie DL, Bell JE, Ironside JW. Preclinical vCJD after blood transfusion in a PRNP codon 129 heterozygous patient. Lancet 2004;364(9433):527-9

Condition

Tuberculosis (Mycobacterium tuberculosis complex)

Individual at risk

Recipient

Guidance at RECRUITMENT

Defer enrolment until two (2) years after completed successful treatment.

Guidance at CT/WORK-UP

Defer donor if within two (2) years of completed successful treatment.

Justification for guidance

There are no documented case reports of tuberculosis (TB) transmission via blood transfusion or HPC transplantation. However, TB is one of the most common bacterial infections transmitted via solid organ transplantation.

There is also a known risk of reactivating pre-existing latent infection in HPC transplant recipients, which is mainly seen in countries with an indigenous risk of TB.

The lack of reports of TB transmission via blood despite the known blood phase of TB infection and the worldwide prevalence of TB suggests that the risk of blood transmission – if it exists – must be extremely low. Extrapolating this assumption to HPC, however, should be done with caution because TB can infect bone and has been detected in bone marrow biopsies of infected patients. A recent study even suggests that bone marrow stem cells are an important reservoir of latent infection.

In this context, the precautionary stance of the current 2-year deferral period following successful treatment of infection seems justified, and is consistent with widely-utilised blood donor selection guidelines (eg the Council of Europe Guide to the preparation, use and quality assurance of blood components).

References

1. Fitzgerald D and Haas DW. Mycobacterium tuberculosis. In: Mandell GL, Bennett JE and Dolin R, ed. Mandell, Douglas and Bennett’s Principles and Practice of Infectious Diseases, 6th ed. Philadelphia: Elsevier Churchill Livingstone, 2005. Vol 2:2852-2886.

2. Ahmad S. Pathogenesis, immunology, and diagnosis of latent Mycobacterium tuberculosis infection. Clin Dev Immunol 2011; Article ID 814943.

3. Golden MP and Vikram HR. Extrapulmonary tuberculosis: an overview. Am Fam Phys 2005; 72:1761-1768.

4. World Health Organisation. Global Tuberculosis Report 2012.

5. NHS. National Institute for Health and Clinical excellence. Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control. Issue date: March 2011.

6. Morris MI, Daly JS, Blumberg E, Kumar D, Sester M, Schluger N, Kim S-H, Schwartz BS, Ison MG, Humar A, Singh N, Michaels M, Orlowski JP, Delmonico F, Pruett T, John GT & Kotton CN. Diagnosis and Management of Tuberculosis in Transplant Donors: A Donor-Derived Infections Consensus Conference Report. American Journal of Transplantation 2012; 12: 2288-2300

7. Ip MSM, Yuen KY, Woo PCY, Luk WK, Tsang KWT, Lam WK & Liang RHS. Risk factors for pulmonary tuberculosis in bone marrow transplant recipients. American Journal of Respiratory and Critical Care Medicine 1998; 158: 1173–1177.

8. Das B, Kashino SS, Pulu I, Kalita D, Swami V, Yeger H, Felsher DW & Campos-Neto A. CD271+ bone marrow mesenchymal stem cells may provide a niche for dormant Mycobacterium tuberculosis. Science Translational Medicine, 5:170ra13, 2013.

9. Council of Europe Guide to the preparation, use and quality assurance of blood components, 16th edition (2010).

COVID-19 VACCINATION

HPC or MNC donation after COVID-19 vaccination

COVID-19 vaccination after HPC or MNC donation

HPC(A) donation does not typically reduce white blood cell numbers, due to G-CSF mobilisation.
HPC(M) donation only causes a minimal reduction in WBC numbers.
This theoretical concern is not specific to COVID-19 vaccines, and there is a lack of existing evidence for such an effect on other vaccines.

Summary tables

AFTER VACCINATION WITH:	DONATION MAY PROCEED:
A COVID-19 vaccine that utilises a virus vector	HPC(A) – schedule G-CSF start date no less than 28 days, and where possible 42 days, after vaccination. HPC(M) & MNC(A) – schedule collection date no less than 28 days, and where possible 42 days, after vaccination.
Any other COVID-19 vaccine	HPC(A) – schedule G-CSF start date no less than 7 days, and where possible 14 days, after vaccination. HPC(M) & MNC(A) – schedule collection date no less than 7 days, and where possible 14 days, after vaccination.
* A shorter interval may be considered after second and subsequent doses of a virus vector-based vaccine, as the risk of TTS is much lower. In addition, donors receiving a booster dose of an mRNA vaccine could be scheduled within 7 days if they have experienced minimal or no reaction to previous doses of the same vaccine – providing that G-CSF/collection does not commence within 24 hours of any unexpected vaccine reaction.

AFTER DONATING:

COVID-19 VACCINATION MAY BE GIVEN:

HPC(M) or

MNC(A)

All vaccines: after the donor has fully recovered from the donation.

HPC(A)

Vaccines based on a virus vector: where available, an alternative vaccine should be used due to the theoretical risk of immune interaction with G-CSF.
Other vaccines: after the donor has fully recovered from the donation.

Condition

Valvular heart disease encompasses a wide range of structural and/or functional heart valve defects. This includes, amongst others:

Aortic stenosis

Aortic regurgitation

Mitral stenosis

Mitral regurgitation

Tricuspid stenosis

Tricuspid regurgitation

Pulmonary stenosis

Pulmonary regurgitation

Mitral valve prolapse

Ebstein anomaly

Individual at Risk

Donor

Guidance at RECRUITMENT/CT/WORK-UP

Acceptable

The following conditions may be acceptable if no ongoing medical care is required, including any medications, and there are no restrictions of activities of daily living:

Mitral valve prolapse in the absence of haemodynamically significant mitral regurgitation and QTc prolongation (obtain pre-operative anaesthetic review if bone marrow collection required)

Minor valve defects (such as mild tricuspid regurgitation) and innocent murmurs

Bicuspid aortic valve without significant stenosis

Unacceptable

Any valve replacement or balloon valvuloplasty

Any clinically significant valvular disease (either by symptoms or echocardiography)

Any congenital valvular stenosis other than biscuspid aortic valve.

Any other valve defect requiring ongoing clinical care or medication, or which causes any restriction in activities of daily living.

Clinical justification

Whilst many valve defects may be asymptomatic in the otherwise healthy donor, the process of bone marrow donation or mobilised stem cell collection may expose such a donor to increased risk of adverse events. These include the arrhythmogenic and vasoactive effect of general anaesthetic and apheresis, risk of bacterial seeding through venous access and risk of thrombosis with G-CSF administration.

The use of prophylactic antibiotics in valve defects is variable and does not have a rigourous evidence base: therefore this should not be used to decide whether or not to accept a donor.

References

Despotis, G.J., Goodnough, L.T., Dynis, M., Baorto, D. & Spitznagel, E.L. (1998) Adverse events in platelet apheresis donors: a multivariate analysis in a hospital-based program. Vox Sanguinis, 77, 24–32

Mittnacht

Condition

Viral haemorrhagic fever, including Ebola and Marburg virus.

Separate guidance exists for Dengue Fever.

Individual at risk

Recipient

Guidance at RECRUITMENT for adult volunteer donor and maternal donor (cord blood donation)

Donors with a history of viral haemorrhagic fever should be deferred for one year following full recovery.

Donors travelling to a country with a history of epidemic Ebola or Marburg fever should be deferred for a minimum of eight weeks from return. In practice, such donors may have a longer period of deferral imposed due to the risk of malaria from travelling to those regions.

Guidance at CT/WORK-UP

Donors with a history of viral haemorrhagic fever should be deferred for one year following full recovery.

Donors travelling to a country with a history of epidemic Ebola or Marburg fever should be deferred for a minimum of eight weeks from return. In practice, such donors may have a longer period of deferral imposed due to the risk of malaria in those regions.

As with malaria, any travel made by the donor to a region with a risk of viral haemorrhagic fever should be reported to the recipient transplant centre.

Justification for guidance

The incubation period for Ebola is 2 to 21 days after exposure to the virus, although 8 to 10 days is most common.

For many registries and donor centres, the risk period for viral haemorrhagic fevers, including Ebola, is covered by a longer deferral period for malaria risk: all countries so far affected by Ebola and Marburg have endemic malaria risk.

However, some registries or donor centres do not defer donors on the basis of malaria risk, or may allow donors to proceed without a deferral period at the transplant centre's discretion: such centres should apply a minimum deferral of eight weeks after return from travel to a country with a risk of viral haemorrhagic fever, including Ebola and Marburg.

At the time of writing, there are two separate 2014 outbreaks of Ebola in Africa:

West Africa:

Liberia

Guinea

Sierra Leone

Central Africa:

Democratic Republic of the Congo

A healthcare worker in Spain caring for a repatriated missionary has been diagnosed with the first case of Ebola contracted outside Africa. There have also been travel-related cases reported in Senegal, Mali and the United States. There have been 2 further cases of locally acquired Ebola virus disease in healthcare workers the US.

In addition, the following African countries have also reported epidemic Ebola or Marburg at some point in the past, unrelated to the current outbreak:

Angola

Congo

Cote D’Ivoire

Gabon

Kenya

South Sudan

Sudan

Uganda

Registries are advised to consult the World Health Organisation website (http://www.who.int/csr/disease/ebola/en/) or the Centre for Disease Control (http://www.cdc.gov/vhf/ebola/index.html) for contemporary information on the 2014 outbreak.

Disclaimer

These guidelines exist as an aid to organisations in assessing the medical suitability of their potential donors. Please be reminded that these guidelines are not intended to supersede local laws or requirements of national legislative bodies.

About the WMDA donor medical suitability guidelines

Guidance provided by the World Marrow Donor Association (WMDA) aims to provide minimum standards by which potential donors should be assessed. The WMDA guidance reflects the consensus opinion of the WMDA donor medical suitability committee. The purpose of this guidance is to provide globally harmonised medical assessment criteria which simultaneously protect the interest of donors whilst ensuring the safety of cellular products across international boundaries.

Whilst this WMDA guidance is not specifically intended for related donors, those involved with the medical assessment of related donors should consider these recommendations.

How donor medical suitability is assessed

Two key concepts govern the assessment of donor health, namely restrictive criteria for donor risk and more permissive criteria for recipient risk

Donor risk

Donation of hematopoietic stem cells (HSC) is an act of altruism, and may be to a recipient in a different country, with quite different moral, cultural and religious values.
Whilst it is recognised that the process of donation carries a small but unavoidable risk of harm to the donor, it is both the moral and legal responsibility of donor registries and donor centres to minimise any avoidable risk. This includes medical conditions that may increase the risk of harm to the donor before, during, and after the collection of HSC.
For this reason, medical criteria governing conditions that may increase donor risk are necessarily stringent, and certainly more so than would be the case if the individual were undergoing a procedure for therapeutic benefit.
In many cases it is difficult to establish a rigorous evidence base as justification for the criteria. In such cases, expert opinion of the underlying physiology of disease will be sought, and combined with knowledge of the known physiological changes associated with donation, as well as experience gained through several decades of HSC donor follow-up and adverse event reporting.
In general, if there is any doubt about the safety of the donor in the presence of a particular medical condition, it will be recommended that any donor with that condition be prevented from donating.

Recipient risk

By contrast, our recommendations regarding conditions that may put the recipient at risk are more lenient.
For many patients, an unrelated donor HSC transplant represents the only possibility of disease cure or long-term remission. Because of the diverse nature of HLA tissue-types, many patients will have a limited number of potentially matched donors. In such cases, donor medical conditions that may present a risk to the recipient alone should be reported to the transplant centre, who are best placed to make an informed risk-benefit judgement on whether to proceed with that particular donor.
There are obvious exceptions to this, however, in particular the carriage of transmissible agents which may have more deleterious effects in the recipient. These include infectious agents such as HIV, viral hepatitis and HTLV, prion-related diseases such as Creutzfeld-Jakob Disease, and carriage of auto-reactive lymphocytes causing multi-system or severe single-organ autoimmune diseases, such as systemic lupus erythematosus, multiple sclerosis or inflammatory bowel disease.

Procedure for creating and reviewing the donor medical suitability guidelines

To create and support this resource, the WMDA has established the donor medical suitability committee. Members of the committee represent all major regions in the world, and are themselves overseen by numerous competent authorities within their country of practice. Committee members are actively involved in donor centre and/or registry operations with experience in matters concerning unrelated donor medical suitability. You can find the members here: https://share.wmda.info/x/So1JAQ.

Submitting a request for review

WMDA welcomes requests for review of individual medical conditions from all those with responsibility for HSC donors, related or unrelated. This may be a medical condition not covered by the current guidance, or a request for clarification or review of current guidance. Requests for new guidance, and feedback on existing guidance, are submitted to the donor medical suitability committee. Comments and justifications for the committee decision are documented, including justification for the decision. Regardless of the outcome, a formal response to the query is provided to the author of each submission in order to inform the registry/donor centre of the outcome of the discussion. Recommendations that are approved are posted to this website. Any controversies pertaining to the recommendations are added to the discussion section on the relevant page. You can click on the button on the right top corner of the page.

Add your question or recommendation at the question section or send an email to mail@wmda.info.

WMDA Recommendations for assessing donor medical suitability

Medical and lifestyle information at enrolment - updated!

Importance	Medical history	Examples of relevant conditions
Recommended	Transmissible and incurable infections with potential risk for the donor	HIV; HTLV
	Serious/inherited blood disorders	Sickle cell disease; thalassaemia major; inherited bleeding disorders
	History of major transplant	Organ; haemopoietic stem cell
	Known cardiovascular disease	Stroke; heart attack
Optional	Cancer	Haematological malignancies
	Autoimmune disease	Especially serious/systemic conditions like multiple sclerosis; systemic lupus erythematosus
	Transmissible infections	Hepatitis B, hepatitis C, syphilis, Chagas disease, malaria
	Potentially transmissible infections	CJD, tuberculosis
	Height and weight	BMI may reflect likely venous access
	General medical history	Past or current medical problems can predict fitness for donation and/or risk to a recipient
	Current medications	Lithium; teratogenic drugs
	Allergies	Especially allergens that may be encountered during donation – latex; anaesthetic

Minimum donor medical and lifestyle information requested at confirmatory/verification typing stage

Medical history	Examples of relevant conditions or questions
Cancer
Autoimmune disease	Ankylosing spondylitis; Crohn’s disease; ulcerative colitis; myasthenia gravis; rheumatoid arthritis; sarcoidosis; SLE; multiple sclerosis; scleroderma/CREST. Any other autoimmune condition
Infectious diseases, including being a sexual partner of an infected individual	HIV, Hepatitis B, Hepatitis C, HTLV, syphilis
Infectious diseases, others	CJD (including familial and exposure risk, e.g. neurosurgery, use of pituitary hormone), Chagas disease, tuberculosis, malaria
Back problems	Any acute or chronic back complaint, including cause, investigations, duration, medication and impact on activities of daily living
Hypertension	Most recent blood pressure readings; medications; degree of control
Cardiac disease	Coronary artery disease; evidence of valve disease, e.g. murmur; arrhythmia
Asthma	Degree of control; medications; use of oral steroids; hospital admissions; intensive care admissions/ventilation
Epilepsy	Medications; date of last seizure
Pregnancy	Number of pregnancies, including miscarriage; current/recent pregnancies; breastfeeding.
Blood transfusion	Receipt of a blood transfusion. Ask year and place of transfusion.
Any other medical history	The potential donor should be asked if they have any other past or current medical problems
Height and weight
High risk sexual behaviour	As defined by the registry’s national competent authority
Non-prescription parenteral drug use
Alcohol consumption
Tattoo, acupuncture or body piercing	When and where. Establish if at an establishment registered according to national regulations
Current medications
Allergies

Medical assessment at work-up - updated!

Medical history as per Table 2, plus:
Travel history	Identify travel to areas with endemic malaria and/or arboviruses such as West Nile virus; dengue; Zika
Place of birth	Identify donors born in an area with endemic Chagas’ disease
Sexual history	Identification of high-risk sexual behaviour, including within groups associated with a higher prevalence of blood-borne infections
Examination	General (including height and weight); cardiovascular (including blood pressure); respiratory; gastrointestinal; neurological
Laboratory investigations (see Table 4 for infectious disease markers)
Haematology	Full blood count; coagulation screen (including PT, APTT and fibrinogen); ESR; blood film; haemoglobin electrophoresis or high-pressure liquid chromatography
Biochemistry	Urea and electrolytes; liver function tests; LDH; ferritin; random glucose; beta-HCG (for females of child-bearing age)
Optional tests	Chest x-ray; electrocardiogram; urinalysis

Recommended minimum testing for infectious disease markers

Stage	Infectious disease	Recommended validated assay
Recruitment	Nil	Nil
CT-stage	HIV	HIV antibody
	Hepatitis B	Hepatitis B surface antigen
	Hepatitis C	Hepatitis C antibody
Work-up	HIV	HIV 1,2 antibody
		p24 antigen
		HIV RNA
	Hepatitis B	Hepatitis B surface antigen
		Hepatitis B surface antibody
		Hepatitis B core antibody
		Hepatitis B DNA
	Hepatitis C	Hepatitis C antibody
		Hepatitis C RNA
	HTLV I+II	HTLV I+II antibody
	Syphilis	Validated serological testing algorithm

Repeating assessments required in the event of a delay to collection - updated!

Time from work-up medical assessment to collection	Repeat assessments required
<=30 days	None
>30 days, <90 days	Required: Infectious disease markers Risk assessment¹ for transmittable disease Full donor history if subsequent donation Optional²: Full donor history if first donation Physical examination All laboratory testing excluding haemoglobinopathy screening Additional testing (per discretion of physician in charge)
>=90 days, <6months	Required: Infectious disease markers Risk assessment for transmittable disease Full donor history if subsequent donation All laboratory testing excluding haemoglobinopathy screening Optional: Full donor history if first donation Physical examination Additional testing (per discretion of physician in charge)
>=6 months	Required: Infectious disease markers Full donor history including risk assessment for transmittable disease Physical examination All laboratory testing excluding haemoglobinopathy screening Optional (per discretion of physician in charge): Additional testing that was performed at the original work-up, such as chest X-ray, ECG or urinalysis.

¹ Risk assessment does not necessarily mean a full risk questionnaire, but means a risk assessment based on local policies, endemic risks and previous individual risk assessments and/or infectious disease marker results. Especially in young donors, a travel history seems appropriate.

²Optional: per discretion of the donor physician in charge or as required by standards or (national) legislation.

Recommended intervals between HPC donations and other blood(product) donations

A WMDA working group is currently reviewing an article that was written on the subject of subsequent donations. Read more on the project and find the article on this page in Share.

WB to HPC interval	If a donor reports donating WB within the last 3 months, report to collection centre physician
Plasmapheresis or plateletphereris to HPC interval	2 weeks
HPC(A) to WB interval	Advise donor to wait 3 months (i.e. equivalent to one WB => WB interval)
HPC(M) to WB interval	Advise donor to wait 6 months (i.e. equivalent to one WB => WB interval)
HPC(A) to plasmapheresis interval	Advise donor to wait 2 weeks (i.e. a typical plasmapheresis => plasmapheresis interval)
HPC(M) to plasmapheresis interval	Advise donor to wait 4 weeks (i.e. a typical WB => plasmapheresis interval)
HPC(A) to plateletpheresis interval	Advise donor to wait 2 weeks (i.e. a typical plateletpheresis => plateletpheresis interval)
HPC(M) to plateletpheresis interval	Advise donor to wait 4 weeks (i.e. a typical WB => plateletpheresis interval)

Contents

A

Acupuncture, see Tattoo, body piercing and acupuncture

Alcohol intake

Alcoholism, see Alcohol intake

Allergy

Alopecia areata, see Single organ autoimmune disease

Anaemia

Anaphylaxis, see Allergy

Angina, see Coronary artery disease

Ankylosing spondylitis, see Back complaints

Antiphospholipid syndrome, see Thrombosis and Thrombophilia

Antithrombin III (ATIII) deficiency, see Thrombosis and Thrombophilia

Aortic regurgitation, see Valvular heart disease

Aortic stenosis, see Valvular heart disease

Arrhythmia

Arterial thrombosis, see Thrombosis and Thrombophilia

Asthma

Atrial fibrillation/flutter, see Arrhythmia

Atopy, see Allergy

B

Babesiosis

Back complaints

Back, fracture, see Back complaints

Back, surgery, see Back complaints

Basal cell carcinoma, see Malignancy

Benign atrial/ventricular ectopics, see Arrhythmia

Benign tumors

Bicuspid aortic valve, see Valvular heart disease

Bipolar affective disorder

Bleeding disorders

Blood pressure, see Hypertension

BMI, see Weight

Body piercing, see Tattoo, body piercing and acupuncture

Breastfeeding, see Pregnancy and breastfeeding

Bronchial asthma, see Asthma

Brugada syndrome, see Arrhythmia

Budd-Chiari syndrome, see Thrombosis and Thrombophilia

C

Cancer, see Malignancy

Cerebral venous sinus thrombosis, see Thrombosis and Thrombophilia

Cerebrovascular disease

Cevical carcinoma in-situ, see Malignancy

Chagas disease

Choreoretinitis, see Inflammatory eye disease

Chronic fatigue syndrome, see Myalgic encephalomyelitis

Chronic obstructive pulmonary disease

CMV, see Cytomegalovirus

Coeliac/celiac disease, see Single organ autoimmune disease

Complete heart block, see Arrhythmia

COAD/COPD, see Chronic obstructive pulmonary disease

Conjunctivitis, see Inflammatory eye disease

Cornea transplant, see Prion-associated disease

Coronary artery disease

Coronavirus, see COVID-19

Coumarin therapy, see Bleeding disorders

COVID-19

Creutzfeld-Jacob disease (CJD, vCJD), see Prion-associated disease

Crohn's disease, see Severe or systemic autoimmune disease

Cytomegalovirus

D

Deep vein thrombosis (DVT), see Thrombosis and Thrombophilia

Dengue Fever

Depression

Diabetes mellitus

E

Ebola, see Viral haemorrhagic fever

Ebstein anomaly, see Valvular heart disease

EBV, see Epstein Barr Virus

Eczema

Endometriosis

Emphysema, see Chronic obstructive pulmonary disease

Endoscopy, see Surgery

Epilepsy

Episcleritis, see Inflammatory eye disease

Epstein Barr Virus

F

Factor II (prothrombin) mutation, see Thrombosis and Thrombophilia

Factor V Leiden, see Thrombosis and Thrombophilia

Fibromyalgia

First degree heart block, see Arrhythmia

G

Glaucoma

Glomerulonephritis, see Renal disease

Goodpasture syndrome, see Severe or systemic autoimmune disease

Graves disease, see Single organ autoimmune disease

Guillain-Barre syndrome, see Severe or systemic autoimmune disease

Gout

H

Haemoglobin disorder

Haemophilia (any type), see Bleeding disorders

Hashimoto thyroiditis, see Single organ autoimmune disease

Hayfever, see Allergy

HbC, HbD, HbE, HbO, see Haemoglobin disorder

Heart attack, see Coronary artery disease

Heart block, see Arrhythmia

Heart murmur, see Valvular heart disease

Hemochromatosis

Heparin therapy, see Bleeding disorders

Hepatitis B

Hepatitis C

Hepatitis E

Hereditary elliptocytosis

Hereditary haemorrhagic telangiectasia, see Bleeding disorders

Herniated intervertebral disc, see Back complaints

Herpes simplex virus

High affinity haemoglobin, see Haemoglobin disorder

High blood pressure, see Hypertension

High risk sexual behaviour

HIV

Hormone replacement therapy, see Prion-associated disease

HSV, see Herpes Simplex Virus

HTLV infection

Hypertension

Hyperthyroidism, see Single organ autoimmune disease

Hypothyroidism, see Single organ autoimmune disease

I

IgA nephropathy, see Renal disease

Immune thrombocytopenia, see Bleeding disorders

Implantable cardiac defibrillator (ICD), see Arrhythmia

Inflammatory bowel disease, see Severe or systemic autoimmune disease

Inflammatory eye disease

Innocent murmur, see Valvular heart disease

Injection of non-prescription drugs

Innoculation injury

Iridocyclitis, see Inflammatory eye disease

Iritis, see Inflammatory eye disease

Ischaemic heart disease (IHD), see Coronary artery disease

J

Jugular vein thrombosis, see Thrombosis and Thrombophilia

K

Kidney stones, see Renal disease

L

Latex allergy, see Allergy

Left bundle branch block, see Arrhythmia

Long-QT syndrome, see Arrhythmia

Lown-Ganong-Levine syndrome, see Arrhythmia

M

Malaria

Malignancy

Manic depressive disorder, see Bipolar affective disorder

Marburg, see Viral haemorrhagic fever

Mitral regurgitation, see Valvular heart disease

Mitral stenosis, see Valvular heart disease

Mitral valve prolapse, see Valvular heart disease

Monoclonal gammopathy of undetermined significance

Multiple sclerosis, see Severe or systemic autoimmune disease

Murmur, see Valvular heart disease

Myalgic encephalomyelitis (ME)

Myocardial infarction (MI), see Coronary artery disease

N

Needlestick injury, see Innoculation injury

Nephrectomy, see Renal disease

Nephritis, see Renal disease

Nephrolithiasis, see Renal disease

Nephrotic syndrome, see Renal disease

O

Obstructive sleep apnoea

Osler-Weber-Rendu syndrome, see Bleeding disorders

Oral anticoagulant therapy, see Bleeding disorders

Osteoporosis

Overweight, see Weight

P

Pacemaker, see Arrhythmia

Paget-Schroetter syndrome, see Thrombosis and Thrombophilia

Pernicious anaemia, see Single organ autoimmune disease

Paroxysmal nocturnal haemoglobinuria (PNH), see Thrombosis and Thrombophilia

Pneumothorax

Portal vein thrombosis, see Thrombosis and Thrombophilia

Pregnancy and breastfeeding

Prion-associated disease

Prolapsed intervertebral disc, see Back complaints

Protein C deficiency, see Thrombosis and Thrombophilia

Protein S deficiency, see Thrombosis and Thrombophilia

Prostitution, see High risk sexual behaviour

Psoriasis, see Single organ autoimmune disease

Pulmonary embolus/embolism (PE), see Thrombosis and Thrombophilia

Pulmonary regurgitation, see Valvular heart disease

Pulmonary stenosis, see Valvular heart disease

Q

R

Renal colic, see Renal disease

Renal disease

Renal vein thrombosis, see Thrombosis and Thrombophilia

Retinitis pigmentosa

Rheumatoid arthritis, see Severe or systemic autoimmune disease

Right bundle branch block, see Arrhythmia

S

Sarcoidosis, see Severe or systemic autoimmune disease

Sciatica, see Back complaints

Scleritis, see Inflammatory eye disease

Scleroderma, see Severe or systemic autoimmune disease

Second degree heart block, see Arrhythmia

Seizure, see Epilepsy

Sex worker, see High risk sexual behaviour

Severe or systemic autoimmune disease

Sickle cell disease, see Haemoglobin disorder

Sickle cell trait, see Haemoglobin disorder

Single organ autoimmune disease

Sinus bradycardia, see Arrhythmia

Sinus tachycardia, see Arrhythmia

Spinal stenosis, see Back complaints

Spondylitis, see Back complaints

Spondylolisthesis, see Back complaints

Stroke, see Cerebrovascular disease

Supraventricular tachycardia, see Arrhythmia

Surgery

SVT, see Arrhythmia

Syphilis

Systemic lupus erythematosus (SLE), see Severe or systemic autoimmune disease

T

Tattoo, body piercing and acupuncture

Thalassaemia, see Haemoglobin disorder

Thrombosis and Thrombophilia

Thrombotic thrombocytopenic purpura (TTP), see Severe or systemic autoimmune disease or Bleeding disorders

Thyroid disease, see Single organ autoimmune disease

Toxoplasmosis

Transfusion

Transient ischaemic attack (TIA), see Cerebrovascular disease

Tuberculosis

U

Ulcerative colitis, see Severe or systemic autoimmune disease

Underweight, see Weight

V

Valvular heart disease

Ventricular tachycardia/fibrillation, see Arrhythmia

Viral haemorrhagic fever

Vitiligo, see Single organ autoimmune disease

Von Willebrand disease (vWD), see Bleeding disorders

Vitamin K deficiency, see Bleeding disorders

W

Warfarin therapy, see Bleeding disorders

Wegener granulomatosis, see Severe or systemic autoimmune disease

Weight

Wenckebach (Mobitz I) heart block, see Arrhythmia

West Nile Virus

Whiplash, see Back complaints

X

Y

Z

Individual at risk

Donor

Guidance at RECRUITMENT for adult volunteer donor (NA for maternal donor (cord blood donation))

ACCEPT if body mass index (BMI) is no greater than 40 kg/m2 and weight is no less than 50 kg.

Registries may consider having no weight criteria at recruitment on the basis that the weight of the donor is likely to change between recruitment and donation, and due to the relative lack of evidence supporting the deferral of over- or underweight donors.

Guidance at CT / WORK-UP

QUALIFIED, see below.

Qualified guidance

ACCEPTABLE for PBSC if weight is at least 50 kg and BMI is no greater than 40.0 kg/m2 (but see below)

ACCEPTABLE for BM if weight is at least 50 kg and BMI is no greater than 35.0 kg/m2 (but see below).

Donors outside these limits at work-up should be discussed with the medical officer who may allow them to proceed after discussion with the responsible physician. Consider the following factors when evaluating donors outside the usual limits:

• With underweight donors, the difference between donor and recipient weight should be considered when assessing realistic harvest targets

• Muscle mass – some individuals with high BMI may not be obese; however, other issues such as anabolic steroid abuse and cardiovascular abnormalities may be relevant.

• General anaesthetic risk – the presence of co-morbidities associated with obesity may increase the risk of general anaesthetic if BM collection is requested or considered as a fallback option. In general, co-morbidities should discourage acceptance of donors above the usual BMI limit for bone marrow collection.

• Venous access – peripheral venous access can be poor in obese donors, and is difficult to assess at confirmatory typing stage unless the registry has an amenable protocol in place or access to relevant records such as blood donation history.

o At CT stage, therefore, the possibility of poor venous access should automatically be flagged for any donor accepted above the usual BMI limit for PBSC collection – with or without any qualifying data such as blood donation history. Depending on registry policy for central venous line insertion, a known history of poor venous access might discourage acceptance of donors above the usual BMI limit for PBSC.

o At Work-up stage, venous access must be carefully assessed by the collection centre. If difficulty in gaining peripheral venous access for PBSC collection is anticipated, and therefore central venous access is considered, additional resources should be applied wherever possible, such as anaesthetic consultation or ultrasound guidance. Registries should have in place a policy for central venous line insertion. Otherwise, it may be more appropriate to reject a donor with BMI above 40 kg/m2 with poor peripheral venous access than to rely on central line placement as an unplanned contingency.

Justification for guidance

The evidence to support this practice is limited. Pulsipher et al. found a slightly increased risk of adverse events in those with a BMI >30. However, much of the rationale for excluding overweight donors lies with two key points: first, BM harvest is technically a considerably more difficult procedure in overweight donors; and, second, there is much evidence to support the concept that the morbidly obese in general (i.e., with a BMI >35) have a higher risk of premature death, anesthetic complications and occult cardiovascular disease.

For the lower weight limit, those donors less than 50 kg stand a higher chance of not achieving the cell dose requested by the harvest centre.

References

Pulsipher MA, Chitphakdithai P, Logan BR, Shaw BE, Wingard JR, Lazarus HM et al. Acute toxicities of unrelated bone marrow versus peripheral blood stem cell donation: results of a prospective trial from the NMDP. Blood 2012. [1]

Adams JP, Murphy PG. Obesity in anaesthesia and intensive care. Br. J. Anaesth.85(1),91–108 (2000) [2]

Condition

West Nile Virus (WNV)

Individual at risk

Donor / Recipient

Guidance at RECRUITMENT for adult volunteer donor and maternal donor (cord blood donation)

Accept if fully recovered Defer if prior infection with residual organ/neurologic deficits

Guidance at CT/WORK-UP

Evaluate for deferral if:

Less than 120 days from diagnosis or onset of symptoms, whichever is later

History of infection with residual organ/neurologic deficits

Justification for guidance

References

FDA Guidance for Industry Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), August 2008

West Nile Transmission via Organ Transplantation and Blood Transfusion---Louisiana, 2008: CDC MMWR 58(45):1263-67.

Notes

WNV has been transmitted via blood transfusions and, theoretically, can be transmitted via stem cell donation. It is an infection caused by a flavivirus commonly found in parts of Africa, western Asia, and the Middle East. It is also present in the United States since 1999. It can reside in animal hosts including birds, mosquitoes, horses, and some other mammals. In 2012 in the US, there were 5,387 cases with 243 deaths. WNV infection can be as short as a few days to as long as several weeks. About 80% of infections are asymptomatic. Because symptoms of WNV infection can be non-specific, FDA donor eligibility guidelines state that the following clinical evidence should be considered when evaluating a potential donor: fever, headache, body aches, or eye pain; occasionally, infections are manifest as truncal rashes or lymphadenopathy. It is estimated that 1 in 50 persons infected develop more severe disease resulting in encephalitis, meningitis, meningoencephalitis, and acute flaccid paralysis. Signs and symptoms of severe infection include headache, high fever, meningismus, altered mental status, coma, tremors, seizures, and muscle weakness.

Although there is limited data one the natural history of the disease, the FDA recommends a 120 day assessment period because of reports of prolonged viremia.

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