Safety and protection of plasma donors: A scoping review and evidence gap map

Natalie Schroyens; Tine D'aes; Emmy De Buck; Susan Mikkelsen; Pierre Tiberghien; Katja van den Hurk; Christian Erikstrup; Veerle Compernolle; Hans Van Remoortel

doi:10.1111/vox.13544

Safety and protection of plasma donors: A scoping review and evidence gap map

Natalie Schroyens, Tine D'aes, Emmy De Buck, Susan Mikkelsen, Pierre Tiberghien, Katja van den Hurk, Christian Erikstrup, Veerle Compernolle, Hans Van Remoortel^*

^*Corresponding author for this work

Department of Clinical Medicine - Department of Clinical Immunology

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaper › Review › Research › peer-review

5 Citations (Scopus)

Abstract

Background and Objectives: As part of a large-scale project to safely increase plasma collection in Europe, the current scoping review identifies the existing evidence (gaps) on adverse events (AEs) and other health effects in plasmapheresis donors, as well as factors that may be associated with such events/effects. Materials and Methods: We searched six databases and three registries. Study characteristics (publication type, language, study design, population, outcomes, associated factors, time of assessment, duration of follow-up, number and frequency of donations, convalescent plasma [y/n], setting and location) were synthesized narratively and in an interactive evidence gap map (EGM). Results: Ninety-four research articles and five registrations were identified. Around 90% were observational studies (57 controlled and 33 uncontrolled), and most of them were performed in Europe (55%) or the United States (20%). Factors studied in association with donor health included donor characteristics (e.g., sex, age) (n = 27), cumulative number of donations (n = 21), donation frequency (n = 11), plasma collection device or programme (n = 11), donor status (first time vs. repeat) (n = 10), donation volume per session (n = 8), time in donation programme (n = 3), preventive measures (n = 2) or other (n = 9). Conclusion: The current scoping review provides an accessible tool for researchers and policymakers to identify the available evidence (gaps) concerning plasmapheresis donation safety. Controlled prospective studies with long-term donor follow-up are scarce. Furthermore, additional experimental studies comparing the health effects of different donation frequencies are required to inform a safe upper limit for donation frequency.

Original language	English
Journal	Vox Sanguinis
Volume	119
Issue	2
Pages (from-to)	110-120
Number of pages	11
ISSN	0042-9007
DOIs	https://doi.org/10.1111/vox.13544
Publication status	Published - Feb 2024

Keywords

adverse events
health effects
plasma donor
plasmapheresis
safety

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10.1111/vox.13544

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@article{c744d4ddeadd4b3d96f2da5008d34d19,

title = "Safety and protection of plasma donors: A scoping review and evidence gap map",

abstract = "Background and Objectives: As part of a large-scale project to safely increase plasma collection in Europe, the current scoping review identifies the existing evidence (gaps) on adverse events (AEs) and other health effects in plasmapheresis donors, as well as factors that may be associated with such events/effects. Materials and Methods: We searched six databases and three registries. Study characteristics (publication type, language, study design, population, outcomes, associated factors, time of assessment, duration of follow-up, number and frequency of donations, convalescent plasma [y/n], setting and location) were synthesized narratively and in an interactive evidence gap map (EGM). Results: Ninety-four research articles and five registrations were identified. Around 90% were observational studies (57 controlled and 33 uncontrolled), and most of them were performed in Europe (55%) or the United States (20%). Factors studied in association with donor health included donor characteristics (e.g., sex, age) (n = 27), cumulative number of donations (n = 21), donation frequency (n = 11), plasma collection device or programme (n = 11), donor status (first time vs. repeat) (n = 10), donation volume per session (n = 8), time in donation programme (n = 3), preventive measures (n = 2) or other (n = 9). Conclusion: The current scoping review provides an accessible tool for researchers and policymakers to identify the available evidence (gaps) concerning plasmapheresis donation safety. Controlled prospective studies with long-term donor follow-up are scarce. Furthermore, additional experimental studies comparing the health effects of different donation frequencies are required to inform a safe upper limit for donation frequency.",

keywords = "adverse events, health effects, plasma donor, plasmapheresis, safety",

author = "Natalie Schroyens and Tine D'aes and {De Buck}, Emmy and Susan Mikkelsen and Pierre Tiberghien and {van den Hurk}, Katja and Christian Erikstrup and Veerle Compernolle and {Van Remoortel}, Hans",

note = "Publisher Copyright: {\textcopyright} 2023 International Society of Blood Transfusion.",

year = "2024",

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doi = "10.1111/vox.13544",

language = "English",

volume = "119",

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TY - JOUR

T1 - Safety and protection of plasma donors

T2 - A scoping review and evidence gap map

AU - Schroyens, Natalie

AU - D'aes, Tine

AU - De Buck, Emmy

AU - Mikkelsen, Susan

AU - Tiberghien, Pierre

AU - van den Hurk, Katja

AU - Erikstrup, Christian

AU - Compernolle, Veerle

AU - Van Remoortel, Hans

PY - 2024/2

Y1 - 2024/2

N2 - Background and Objectives: As part of a large-scale project to safely increase plasma collection in Europe, the current scoping review identifies the existing evidence (gaps) on adverse events (AEs) and other health effects in plasmapheresis donors, as well as factors that may be associated with such events/effects. Materials and Methods: We searched six databases and three registries. Study characteristics (publication type, language, study design, population, outcomes, associated factors, time of assessment, duration of follow-up, number and frequency of donations, convalescent plasma [y/n], setting and location) were synthesized narratively and in an interactive evidence gap map (EGM). Results: Ninety-four research articles and five registrations were identified. Around 90% were observational studies (57 controlled and 33 uncontrolled), and most of them were performed in Europe (55%) or the United States (20%). Factors studied in association with donor health included donor characteristics (e.g., sex, age) (n = 27), cumulative number of donations (n = 21), donation frequency (n = 11), plasma collection device or programme (n = 11), donor status (first time vs. repeat) (n = 10), donation volume per session (n = 8), time in donation programme (n = 3), preventive measures (n = 2) or other (n = 9). Conclusion: The current scoping review provides an accessible tool for researchers and policymakers to identify the available evidence (gaps) concerning plasmapheresis donation safety. Controlled prospective studies with long-term donor follow-up are scarce. Furthermore, additional experimental studies comparing the health effects of different donation frequencies are required to inform a safe upper limit for donation frequency.

AB - Background and Objectives: As part of a large-scale project to safely increase plasma collection in Europe, the current scoping review identifies the existing evidence (gaps) on adverse events (AEs) and other health effects in plasmapheresis donors, as well as factors that may be associated with such events/effects. Materials and Methods: We searched six databases and three registries. Study characteristics (publication type, language, study design, population, outcomes, associated factors, time of assessment, duration of follow-up, number and frequency of donations, convalescent plasma [y/n], setting and location) were synthesized narratively and in an interactive evidence gap map (EGM). Results: Ninety-four research articles and five registrations were identified. Around 90% were observational studies (57 controlled and 33 uncontrolled), and most of them were performed in Europe (55%) or the United States (20%). Factors studied in association with donor health included donor characteristics (e.g., sex, age) (n = 27), cumulative number of donations (n = 21), donation frequency (n = 11), plasma collection device or programme (n = 11), donor status (first time vs. repeat) (n = 10), donation volume per session (n = 8), time in donation programme (n = 3), preventive measures (n = 2) or other (n = 9). Conclusion: The current scoping review provides an accessible tool for researchers and policymakers to identify the available evidence (gaps) concerning plasmapheresis donation safety. Controlled prospective studies with long-term donor follow-up are scarce. Furthermore, additional experimental studies comparing the health effects of different donation frequencies are required to inform a safe upper limit for donation frequency.

KW - adverse events

KW - health effects

KW - plasma donor

KW - plasmapheresis

KW - safety

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U2 - 10.1111/vox.13544

DO - 10.1111/vox.13544

M3 - Review

C2 - 37814964

AN - SCOPUS:85173780802

SN - 0042-9007

VL - 119

SP - 110

EP - 120

JO - Vox Sanguinis

JF - Vox Sanguinis

IS - 2

ER -

Safety and protection of plasma donors: A scoping review and evidence gap map

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