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

Natalie Schroyens · Tine D’aes · Emmy D.J. De Buck · Susan Mikkelsen · Pierre Tiberghien · Katja van den Hurk +3 more

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Blood donation and transfusion practices Blood transfusion and management Ethics in Clinical Research

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.

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2018PRISMA Extension for Scoping Reviews (PRISMA-ScR): Checklist and Explanation 2022PRISMA2020 : An R package and Shiny app for producing PRISMA 2020‐compliant flow diagrams, with interactivity for optimised digital transparency and Open Synthesis 2022What are scoping reviews? Providing a formal definition of scoping reviews as a type of evidence synthesis 2023Mapping reviews, scoping reviews, and evidence and gap maps (EGMs): the same but different— the “Big Picture” review family 2006A prospective multicentre study on the safety of long‐term intensive plasmapheresis in donors (SIPLA)1964Effects of Intensive Plasmapheresis on Normal Blood Donors 2010Specific protein content of pools of plasma for fractionation from different sources: impact of frequency of donations 2009Adverse reactions in blood and apheresis donors: experience from two Italian transfusion centres.

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2024The effect of donation frequency on donor health in blood donors donating plasma by plasmapheresis: study protocol for a randomized controlled trial 2023Very‐high frequency plasmapheresis and donor health–absence of evidence is not equal to evidence of absence 2024Balancing Donor Health and Plasma Collection: A Systematic Review of the Impact of Plasmapheresis Frequency

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