Researchers in Transfusion examined source plasma donation frequency effects and their impact on donor health. Specifically, the authors addressed whether the current source plasma (SP) donation frequency and volume limits allowed by regulators “impacts donors’ self-reported functional health and well-being.” The cross-sectional study performed by the Plasma Protein Therapeutics Association (PPTA) “hypothesized that the current SP procedures and donation frequency does not impair self-reported donor functional health and well-being.”
The authors explained that 14 centers operated by three different SP collectors participated in the study across the U.S. Those enrolled in the study “completed a self-administered survey assessing health-related quality of life (HRQoL) and frequency of various health conditions. HRQoL was assessed using the SF-36v2® Health Survey (SF-36v2), a 36-item measure of generic HRQoL in the past four weeks.” The study included 5,608 SP donors with 3,434 completing the baseline survey. “Approximately the same number of males and females completed the surveys. The overall mean age for females was slightly higher than males (38.5 vs 36.7 years). Very High Frequency Donors were older than New Donors by seven (male) to 10 (female) years. The mean body mass index (BMI) for females were slightly higher than males (32.5 vs 29.9), however there was minimal difference between the four donation frequency groups. The majority (70 percent) of donors were non-Hispanic White.”
The researchers found that, “[a]mong males, there were no statistically or clinically significant differences in mean scale scores related to physical well-being when higher frequency donor groups were compared with the New Donor group based on the unadjusted or adjusted models…With the exception of the physical functioning scale, there were no statistically significant differences among females in the four donation frequency groups in predicted mean scale scores related to physical well-being based on the unadjusted models.”
The study concluded that, “[a]ll SP donor frequency groups had the same or better scores on multiple indicators of HRQoL as compared with an external benchmark for healthy adults in the U.S. population. After controlling for potential confounding and accounting for multiple comparisons among males and females, there were no statistically significant differences in HRQoL scores between each frequency group relative to the New Donor group, indicating that frequent donors, including Very High Frequency Donors, had similar findings to New Donors. For the self-evaluated transition, only a few participants (3 percent) reported they were worse now than one year ago and most participants (97 percent) reported they were the same or better…[The authors] acknowledged that a cross-sectional analysis cannot account for temporal relationships, and therefore, longitudinal designs are needed to confirm results.”
They added that, “the data in this study support the hypothesis that compensated SP donations at the frequency and volumes permitted by the U.S. Food and Drug Administration are consistent with favorable self-reported donor functional health and well-being. Plasmapheresis itself, even at the highest frequency level, is not associated with negative self-reported health impacts. The lower immunoglobulin levels, which have been previously reported in some studies, likely represent a temporary reduction due to the plasmapheresis procedure rather than a true risk of immunodeficiency and associated clinical signs, such as infections.”Citation: Fransen, M., Becker, M., Hershman, J. et al. “Effects of donation frequency on U.S. source plasma donor health.” Transfusion. 2023