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Balancing Donor Health and Plasma Collection: A Systematic Review of the Impact of Plasmapheresis Frequency.
D'aes, Tine; van den Hurk, Katja; Schroyens, Natalie; Mikkelsen, Susan; Severijns, Pieter; De Buck, Emmy; O'Leary, Peter; Tiberghien, Pierre; Compernolle, Veerle; Erikstrup, Christian; Van Remoortel, Hans.
Afiliación
  • D'aes T; Centre for Evidence-Based Practice, Belgian Red Cross, Mechelen, Belgium; Department of Public Health and Primary Care, Leuven Institute for Healthcare Policy, Leuven, Belgium.
  • van den Hurk K; Donor Health, Sanquin Research, Amsterdam, the Netherlands; Department of Public and Occupational Health and the Amsterdam Public Health (APH) Research Institute, Amsterdam UMC, Amsterdam, The Netherlands.
  • Schroyens N; Centre for Evidence-Based Practice, Belgian Red Cross, Mechelen, Belgium; Department of Public Health and Primary Care, Leuven Institute for Healthcare Policy, Leuven, Belgium.
  • Mikkelsen S; Department of Clinical Immunology, Aarhus University Hospital, Aarhus, Denmark.
  • Severijns P; Centre for Evidence-Based Practice, Belgian Red Cross, Mechelen, Belgium.
  • De Buck E; Centre for Evidence-Based Practice, Belgian Red Cross, Mechelen, Belgium; Department of Public Health and Primary Care, Leuven Institute for Healthcare Policy, Leuven, Belgium.
  • O'Leary P; European Blood Alliance, BLSI, Brussels, Belgium.
  • Tiberghien P; Université de Franche-Comté, Etablissement Français du Sang, INSERM, UMR RIGHT, Besançon, France; Etablissement Français du Sang, France.
  • Compernolle V; Belgian Red Cross, Blood Services, Mechelen, Belgium; Faculty of Medicine and Health Sciences, University of Ghent, Ghent, Belgium.
  • Erikstrup C; Department of Clinical Immunology, Aarhus University Hospital, Aarhus, Denmark; Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
  • Van Remoortel H; Centre for Evidence-Based Practice, Belgian Red Cross, Mechelen, Belgium; Department of Public Health and Primary Care, Leuven Institute for Healthcare Policy, Leuven, Belgium. Electronic address: hans.vanremoortel@rodekruis.be.
Transfus Med Rev ; : 150851, 2024 Aug 21.
Article en En | MEDLINE | ID: mdl-39244430
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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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Transfus Med Rev Asunto de la revista: HEMATOLOGIA Año: 2024 Tipo del documento: Article País de afiliación: Bélgica Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Transfus Med Rev Asunto de la revista: HEMATOLOGIA Año: 2024 Tipo del documento: Article País de afiliación: Bélgica Pais de publicación: Estados Unidos