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

Abstract

Background and ObjectivesMost research studies on the effects of repeated plasma donation are observational with different study limitations, resulting in high uncertainty on the link between repeated plasma donation and health consequences. Here, we prospectively investigated the safety of intensive or less intensive plasma donation protocols.Materials and MethodsSixty‐three male subjects participated in this randomized controlled trial and were divided into low‐frequency (LF, once/month, n = 16), high‐frequency (HF, three times/month, n = 16), very high‐frequency (VHF, two times/week, n = 16) and a placebo (P, once/month, n = 15) groups. Biochemical, haematological, clinical, physiological and exercise‐related data were collected before (D0), after 1½ months (D42) and after 3 months (D84) of donation.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, plasma levels of albumin, immunoglobulin G (IgG), immunoglobulin A (IgA) and immunoglobulin M (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 were reported in HF and VHF. Repeated plasma donation had no effect on blood pressure, body composition or exercise performance.ConclusionVHF plasmapheresis may result in a large reduction in ferritin and IgG levels. HF and VHF plasmapheresis may result in little to no difference in other biochemical, haematological, clinical, physiological and exercise‐related parameters.

The availability of plasma donors and plasma: A sociologist's perspective

“…For PDMPs, many pathogenreduction steps during manufacture have increased safety considerably [30]. At the same time, there is increasing worry that too frequent plasma donation takes a toll on donor health [31][32][33], especially in the context of paid donors with a call for high-quality and systematic evidence based on international criteria [33]. The recent debate, for example, around European policymaking about the new regulation on substances of human origin is clear on endorsing the importance of donor safety, the principle of voluntary non-remunerated donations, but allows donor appropriate compensation and reimbursement of donors in line with national legislations.…”

Balancing donor health and plasma collection: a systematic review of the impact of plasmapheresis frequency

“…Of the six included studies, two studies were conducted in Croatia [23,24], two in the US [25,26], one in Canada [27], and one in Belgium [16]. The studies comprised four observational [23][24][25][26], and two experimental studies [16,27].…”

“…In addition, we found one registration of a randomized controlled trial (RCT) that will be conducted in Norway [28] (Table 1). The included studies were mostly older, with one study conducted in the early 1970s [26], two in the early 1980s [23,24], one in the early 1990s [27], one in the early 2010s [25] and only one very recent paper [16]. For an overview of the study characteristics, see Table 1.…”

“…The following outcomes relating to cardiovascular health were assessed in the included studies: change in low-density lipoprotein (LDL), high-density lipoprotein (HDL) or total cholesterol [25], glycemia [16], insulinemia [16], glycated haemoglobin (HbA1C) [16], total cholesterol [16], systolic blood pressure [16], diastolic blood pressure [16], body mass [16], body mass index (BMI) [16], bone mineral content [16], fat mass [16], fat-free mass [16], fat-free mass + bone mineral content [16], fat percentage [16], lactate during cycling at 190 W [16], lactate after cycling [16], maximum heart rate [16], maximal ventilation [16], peak oxygen consumption [16], and oxygen pulse [16].…”

“…The RCT by Mortier et al [16] was the only included study to investigate the effect of plasmapheresis frequency on adverse event occurrence. No adverse events were recorded in donors undergoing sham or monthly plasmapheresis.…”