Effects of plasmapheresis frequency on health status and exercise performance in men: a randomized controlled trial

Abstract

ABSTRACTObjectivesTo collect data on 1) haematological and biochemical markers, 2) physiological and exercise-related parameters and 3) adverse events to get a comprehensive picture of the safety of intensive or less intensive plasma donation protocols.MethodsSixty-three male subjects participated in this randomized controlled trial and were divided into a low-frequency (LF, 1x/month, n=16), high-frequency (HF, 3x/month, n=16), very high-frequency (VHF, 2x/week, n=16) and a placebo (P, 1x/month, n=15) group. Biochemical, haematological, clinical, physiological and sport performance-related data were collected before (D0), after 1½ month (D42) and after 3 months (D84).ResultsIn VHF, red blood cells, haemoglobin and haematocrit levels decreased while reticulocyte levels increased from D0 to D84. In both HF and VHF, plasma ferritin levels were lower at D42 and D84 compared to D0. In VHF, the plasma levels of albumin, IgG, IgA and IgM dropped from D0 to D42 and remained lower at D84 than at D0. In HF, plasma IgG, IgA and IgM were lower at D42 and IgG and IgM were lower at D84 compared to D0. Few adverse events (haematoma, anaemia, vasovagal reactions without syncope) were reported in HF and VHF. Repeated plasma donation had no effect on blood pressure, body composition or exercise performance.ConclusionHaematological and biochemical parameters were severely impacted when plasmapheresis was repeated twice a week, mildly impacted with a frequency of three times per month and not impacted with a frequency of once a month. Despite those changes, markers for exercise performance were not altered when plasmapheresis, whatever the frequency, was repeated over 3 months.Summary Box:What is already known on this topic?Plasmapheresis may induce a series of health consequences, such as adverse events of diverse severities. However, those events have mainly been studied separately and retrospectively with no appropriate placebo group.What this study adds?This is the first randomized controlled trial prospectively investigating the effects of repeated plasma donation on a whole range of health consequences, namely biochemical and haematological, blood pressure, body composition, adverse events and, exercise performance.How this study might affect research, practice or policy?Worldwide efforts need to be made to increase the amount of plasma collected for manufacturing plasma-derived product. To avoid negative effects to donors, a sustainable plasma supply should be based on a large donorbase of low-frequency donors.