Adverse events among 2408 unrelated donors of peripheral blood stem cells: results of a prospective trial from the National Marrow Donor Program

Limited data are available describing donor adverse events (AEs) associated with filgrastim mobilized peripheral blood stem cell (PBSC) collections in unrelated volunteers. We report results in 2408 unrelated PBSC donors prospectively evaluated by the National Marrow Donor Program (NMDP) between 199...

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Bibliographic Details
Published in:Blood 2009-04, Vol.113 (15), p.3604-3611
Main Authors: Pulsipher, Michael A., Chitphakdithai, Pintip, Miller, John P., Logan, Brent R., King, Roberta J., Rizzo, J. Douglas, Leitman, Susan F., Anderlini, Paolo, Haagenson, Michael D., Kurian, Seira, Klein, John P., Horowitz, Mary M., Confer, Dennis L.
Format: Article
Language:English
Subjects:
Adolescent
Adult
Age Distribution
Biological and medical sciences
Blood Cell Count
Blood Component Removal - adverse effects
Blood Component Removal - statistics & numerical data
Blood Donors
Fatigue - epidemiology
Female
Filgrastim
Follow-Up Studies
Granulocyte Colony-Stimulating Factor - adverse effects
Hematologic and hematopoietic diseases
Hematopoietic Stem Cell Mobilization - adverse effects
Hematopoietic Stem Cell Mobilization - statistics & numerical data
Hematopoietic Stem Cell Transplantation
Humans
Incidence
Logistic Models
Male
Medical sciences
Middle Aged
Obesity - epidemiology
Pain - epidemiology
Prospective Studies
Recombinant Proteins
Risk Factors
Sex Distribution
Transfusion Medicine
Young Adult
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Summary:Limited data are available describing donor adverse events (AEs) associated with filgrastim mobilized peripheral blood stem cell (PBSC) collections in unrelated volunteers. We report results in 2408 unrelated PBSC donors prospectively evaluated by the National Marrow Donor Program (NMDP) between 1999 and 2004. Female donors had higher rates of AEs, requiring central line placement more often (17% vs 4%, P < .001), experiencing more apheresis-related AEs (20% vs 7%, P < .001), more bone pain (odds ratio [OR] = 1.49), and higher rates of grades II-IV and III-IV CALGB AEs (OR = 2.22 and 2.32). Obese donors experienced more bone pain (obese vs normal, OR = 1.73) and heavy donors had higher rates of CALGB toxicities (> 95 kg vs < 70 kg, OR = 1.49). Six percent of donors experienced grade III-IV CALGB toxicities and 0.6% experienced toxicities that were considered serious and unexpected. Complete recovery is universal, however, and no late AEs attributable to donation have been identified. In conclusion, PBSC collection in unrelated donors is generally safe, but nearly all donors will experience bone pain, 1 in 4 will have significant headache, nausea, or citrate toxicity, and a small percentage will experience serious short-term adverse events. In addition, women and larger donors are at higher risk for donation-related AEs.
ISSN:0006-4971
1528-0020
DOI:10.1182/blood-2008-08-175323