Balancing Donor Health and Plasma Collection: A Systematic Review of the Impact of Plasmapheresis Frequency

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

doi:10.1016/j.tmrv.2024.150851

Balancing Donor Health and Plasma Collection: A Systematic Review of the Impact of Plasmapheresis Frequency

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

^*Corresponding author af dette arbejde

Institut for Klinisk Medicin - Immunologi

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avis › Tidsskriftartikel › Forskning › peer review

Abstract

Most plasma used for manufacturing plasma-derived medicinal products (PDMPs) such as albumin, immunoglobulin (Ig), and clotting factors is obtained from source plasma collected via plasmapheresis, the majority of which is contributed by the United States (US). While the demand for PDMPs continues to rise, it remains unclear whether high-frequency plasmapheresis, such as the twice-weekly plasma donation allowed in the US, may have any (long-term) adverse health effects on the donor. To investigate the frequency at which plasma can be donated without harm to the donor, the current systematic review explores the impact of plasma donation frequency on cardiovascular health, protein depletion, and adverse events in healthy plasma donors. We asked the following research question: What is the impact of plasmapheresis frequency (Intervention) on the safety or health (Outcome) of healthy donors (Population)? Six databases (PubMed, Embase, Web of Science, CINAHL, the Cochrane Library, and Transfusion Evidence Library), 2 clinical trial registries (ICTRP and clinicaltrials.gov), and the PROSPERO database were searched. Four observational and 2 experimental studies were included. The results showed that very high-frequency donation (twice per week) may result in a clinically relevant decrease in ferritin and bring IgG levels below the lower threshold of 6 g/l. However, the evidence is of low to very low certainty, and solid conclusions are hindered by the healthy donor effect and methodological limitations of the included studies. To determine a safe threshold donation frequency that minimizes any possible harmful effect on the donor, more high-quality prospective cohort studies and experimental studies are needed. We should expedite such studies to support recommendations, as conclusive evidence confirming or refuting the safety of maximum allowed donation frequencies is lacking. Donor protection is essential, given that healthy donors receive no direct medical benefit from donating plasma.

Originalsprog	Engelsk
Artikelnummer	150851
Tidsskrift	Transfusion Medicine Reviews
Vol/bind	38
Nummer	4
ISSN	0887-7963
DOI	https://doi.org/10.1016/j.tmrv.2024.150851
Status	Udgivet - okt. 2024

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10.1016/j.tmrv.2024.150851Licens: CC BY

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D'aes, T., van den Hurk, K., Schroyens, N., Mikkelsen, S., Severijns, P., De Buck, E., O'Leary, P., Tiberghien, P., Compernolle, V., Erikstrup, C., & Van Remoortel, H. (2024). Balancing Donor Health and Plasma Collection: A Systematic Review of the Impact of Plasmapheresis Frequency. Transfusion Medicine Reviews, 38(4), Artikel 150851. https://doi.org/10.1016/j.tmrv.2024.150851

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title = "Balancing Donor Health and Plasma Collection: A Systematic Review of the Impact of Plasmapheresis Frequency",

abstract = "Most plasma used for manufacturing plasma-derived medicinal products (PDMPs) such as albumin, immunoglobulin (Ig), and clotting factors is obtained from source plasma collected via plasmapheresis, the majority of which is contributed by the United States (US). While the demand for PDMPs continues to rise, it remains unclear whether high-frequency plasmapheresis, such as the twice-weekly plasma donation allowed in the US, may have any (long-term) adverse health effects on the donor. To investigate the frequency at which plasma can be donated without harm to the donor, the current systematic review explores the impact of plasma donation frequency on cardiovascular health, protein depletion, and adverse events in healthy plasma donors. We asked the following research question: What is the impact of plasmapheresis frequency (Intervention) on the safety or health (Outcome) of healthy donors (Population)? Six databases (PubMed, Embase, Web of Science, CINAHL, the Cochrane Library, and Transfusion Evidence Library), 2 clinical trial registries (ICTRP and clinicaltrials.gov), and the PROSPERO database were searched. Four observational and 2 experimental studies were included. The results showed that very high-frequency donation (twice per week) may result in a clinically relevant decrease in ferritin and bring IgG levels below the lower threshold of 6 g/l. However, the evidence is of low to very low certainty, and solid conclusions are hindered by the healthy donor effect and methodological limitations of the included studies. To determine a safe threshold donation frequency that minimizes any possible harmful effect on the donor, more high-quality prospective cohort studies and experimental studies are needed. We should expedite such studies to support recommendations, as conclusive evidence confirming or refuting the safety of maximum allowed donation frequencies is lacking. Donor protection is essential, given that healthy donors receive no direct medical benefit from donating plasma.",

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

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doi = "10.1016/j.tmrv.2024.150851",

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AU - van den Hurk, Katja

AU - Schroyens, Natalie

AU - Mikkelsen, Susan

AU - Severijns, Pieter

AU - De Buck, Emmy

AU - O'Leary, Peter

AU - Tiberghien, Pierre

AU - Compernolle, Veerle

AU - Erikstrup, Christian

AU - Van Remoortel, Hans

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Balancing Donor Health and Plasma Collection: A Systematic Review of the Impact of Plasmapheresis Frequency

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