Serious Adverse Events in Related Donors: A Report from the Related Donor Safe Study

Matthew D. Seftel; Pintip Chitphakdithai; John P. Miller; Hati Kobusingye; Brent R. Logan; Michael Linenberger; Andrew S. Artz; Ann E. Haight; David A. Jacobsohn; Mark R. Litzow; Margarida Magalhaes-Silverman; George B. Selby; Madhuri Vusirikala; Mary M. Horowitz; Galen E. Switzer; Dennis L. Confer; Bronwen E. Shaw; Michael A. Pulsipher

doi:10.1016/j.jtct.2021.01.009

Serious Adverse Events in Related Donors: A Report from the Related Donor Safe Study

Matthew D. Seftel, Pintip Chitphakdithai, John P. Miller, Hati Kobusingye, Brent R. Logan, Michael Linenberger, Andrew S. Artz, Ann E. Haight, David A. Jacobsohn, Mark R. Litzow, Margarida Magalhaes-Silverman, George B. Selby, Madhuri Vusirikala, Mary M. Horowitz, Galen E. Switzer, Dennis L. Confer, Bronwen E. Shaw, Michael A. Pulsipher

Hematology

Research output: Contribution to journal › Article › peer-review

Abstract

The incidence and risk factors for severe adverse events (SAEs) in related donors (RD) of hematopoietic cell transplants is unknown. The Related Donor Safe study is a prospective observational cohort of 1680 RDs and represents an opportunity to examine characteristics of SAEs in RDs. In this cohort, we found that SAEs were reported in a total 12 (0.71%) RDs. Of these, 5 SAEs occurred in bone marrow donors (5/404, 1.24%), and 7 (7/1276, 0.55%) were in donors of peripheral blood stem cells. All of the SAEs were considered to be related (definite, probable, or possible) to the donation process. There were no donor fatalities. Of the 12 RDs who experienced an SAE, 10 were either overweight or obese. Five of the 12 RDs had predonation medical conditions that would have resulted in either possible or definite ineligibility for donation were they being assessed as unrelated donors. These SAE data will be useful in the counseling of prospective RDs before planned donation and may be helpful in identifying donors who should be considered medically unsuitable for donation.

Original language	English (US)
Pages (from-to)	352.e1-352.e5
Journal	Transplantation and Cellular Therapy
Volume	27
Issue number	4
DOIs	https://doi.org/10.1016/j.jtct.2021.01.009
State	Published - Apr 2021

Keywords

Adverse events
Allogeneic hematopoietic cell transplantation
Related donors

ASJC Scopus subject areas

Transplantation
Molecular Medicine
Hematology
Immunology and Allergy
Cell Biology

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10.1016/j.jtct.2021.01.009

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Seftel, M. D., Chitphakdithai, P., Miller, J. P., Kobusingye, H., Logan, B. R., Linenberger, M., Artz, A. S., Haight, A. E., Jacobsohn, D. A., Litzow, M. R., Magalhaes-Silverman, M., Selby, G. B., Vusirikala, M., Horowitz, M. M., Switzer, G. E., Confer, D. L., Shaw, B. E., & Pulsipher, M. A. (2021). Serious Adverse Events in Related Donors: A Report from the Related Donor Safe Study. Transplantation and Cellular Therapy, 27(4), 352.e1-352.e5. https://doi.org/10.1016/j.jtct.2021.01.009

Seftel, MD, Chitphakdithai, P, Miller, JP, Kobusingye, H, Logan, BR, Linenberger, M, Artz, AS, Haight, AE, Jacobsohn, DA, Litzow, MR, Magalhaes-Silverman, M, Selby, GB, Vusirikala, M, Horowitz, MM, Switzer, GE, Confer, DL, Shaw, BE & Pulsipher, MA 2021, 'Serious Adverse Events in Related Donors: A Report from the Related Donor Safe Study', Transplantation and Cellular Therapy, vol. 27, no. 4, pp. 352.e1-352.e5. https://doi.org/10.1016/j.jtct.2021.01.009

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abstract = "The incidence and risk factors for severe adverse events (SAEs) in related donors (RD) of hematopoietic cell transplants is unknown. The Related Donor Safe study is a prospective observational cohort of 1680 RDs and represents an opportunity to examine characteristics of SAEs in RDs. In this cohort, we found that SAEs were reported in a total 12 (0.71%) RDs. Of these, 5 SAEs occurred in bone marrow donors (5/404, 1.24%), and 7 (7/1276, 0.55%) were in donors of peripheral blood stem cells. All of the SAEs were considered to be related (definite, probable, or possible) to the donation process. There were no donor fatalities. Of the 12 RDs who experienced an SAE, 10 were either overweight or obese. Five of the 12 RDs had predonation medical conditions that would have resulted in either possible or definite ineligibility for donation were they being assessed as unrelated donors. These SAE data will be useful in the counseling of prospective RDs before planned donation and may be helpful in identifying donors who should be considered medically unsuitable for donation.",

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AU - Linenberger, Michael

AU - Artz, Andrew S.

AU - Haight, Ann E.

AU - Jacobsohn, David A.

AU - Litzow, Mark R.

AU - Magalhaes-Silverman, Margarida

AU - Selby, George B.

AU - Vusirikala, Madhuri

AU - Horowitz, Mary M.

AU - Switzer, Galen E.

AU - Confer, Dennis L.

AU - Shaw, Bronwen E.

AU - Pulsipher, Michael A.

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AB - The incidence and risk factors for severe adverse events (SAEs) in related donors (RD) of hematopoietic cell transplants is unknown. The Related Donor Safe study is a prospective observational cohort of 1680 RDs and represents an opportunity to examine characteristics of SAEs in RDs. In this cohort, we found that SAEs were reported in a total 12 (0.71%) RDs. Of these, 5 SAEs occurred in bone marrow donors (5/404, 1.24%), and 7 (7/1276, 0.55%) were in donors of peripheral blood stem cells. All of the SAEs were considered to be related (definite, probable, or possible) to the donation process. There were no donor fatalities. Of the 12 RDs who experienced an SAE, 10 were either overweight or obese. Five of the 12 RDs had predonation medical conditions that would have resulted in either possible or definite ineligibility for donation were they being assessed as unrelated donors. These SAE data will be useful in the counseling of prospective RDs before planned donation and may be helpful in identifying donors who should be considered medically unsuitable for donation.

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Serious Adverse Events in Related Donors: A Report from the Related Donor Safe Study

Abstract

Keywords

ASJC Scopus subject areas

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