Haugen Morten, Magnussen Karin, Aarsland Tonje Eiane, Nissen-Meyer Lise Sofie Haug, Strand Tor A
Department of Immunology and Transfusion Medicine, Innlandet Hospital Trust, Anders Sandvigs Gate 17, 2609, Lillehammer, Norway.
Faculty of Medicine, University of Oslo, Oslo, Norway.
Trials. 2024 Mar 11;25(1):175. doi: 10.1186/s13063-024-08035-7.
The demand for plasma products is growing, necessitating an increase in plasma collection by plasmapheresis. While the 20th edition of the European Guidelines permits plasma donors in Europe to donate with 96-h donation intervals, the potential short- and long-term consequences of high-frequency plasma donations on donor health remain unknown. This study aims to measure the effect of plasma donation frequency on plasma protein composition, including total serum protein (TSP) and immunoglobulin G (IgG), in Norwegian male blood donors.
This randomized controlled trial (RCT) included 120 male blood donors who were randomized into two intervention groups and one control group: high-frequency plasma donors (HFPDs) who donated 650 mL of plasma 3 times every 2 weeks, whereas regular-frequency plasma donors (RFPDs) who donated 650 mL of plasma 1 time every 2 weeks. The control group consisted of whole blood donors. The primary outcomes are the concentrations of TSP and IgG.
The findings from this study may have implications for recommendations related to donor health and plasma donation frequencies and may contribute to supporting the strategic independence of plasma products in Norway and Europe without compromising donor health.
ClinicalTrials.gov: NCT05179200 . Registered December 20th, 2021.
对血浆制品的需求不断增长，这使得通过血浆单采增加血浆采集量成为必要。虽然欧洲指南第20版允许欧洲的血浆捐献者以96小时的捐献间隔进行捐献，但高频血浆捐献对捐献者健康的潜在短期和长期影响仍不明确。本研究旨在测量血浆捐献频率对挪威男性献血者血浆蛋白组成的影响，包括总血清蛋白（TSP）和免疫球蛋白G（IgG）。
这项随机对照试验（RCT）纳入了120名男性献血者，他们被随机分为两个干预组和一个对照组：高频血浆捐献者（HFPDs）每2周捐献3次650毫升血浆，而常规频率血浆捐献者（RFPDs）每2周捐献1次650毫升血浆。对照组由全血捐献者组成。主要结局指标是TSP和IgG的浓度。
本研究的结果可能对与捐献者健康和血浆捐献频率相关的建议产生影响，并可能有助于在不损害捐献者健康的情况下支持挪威和欧洲血浆制品的战略独立性。
ClinicalTrials.gov：NCT05179200。于2021年12月20日注册。
