Donor safety in an individualized plasmapheresis program – Results of an interim analysis

Abstract

Background and objectivesAlthough plasma donation by plasmapheresis is generally considered to be safe, there are still concerns about the long-term effects of intensive plasma donation on the levels of certain blood components, such as immunoglobulin G (IgG). The IPS study aims to assess donor safety during individualized plasma donation according to pre-donation IgG levels and body weight compared with plasma donation under current German guidelines. Study design and methodsThis ongoing prospective multicenter study allows eligible donors to choose between an individualized plasma donation program or plasma donation according to current German guidelines. Adverse events (AEs), serious AEs (SAEs) and serum IgG levels are systematically documented for up to 12 years, with AE/SAE recording from study start until 8 months after the last donation on-study. ResultsAt data cut-off (30 th June 2019), 1,919,334 donations in 20,598 donors were documented. The donation-based incidence for all AEs/SAEs was 2.07% in the control group (n = 2155) and 2.22% in the individualized program group (n = 18,443). For related AEs/SAEs, incidences were 1.23% and 1.62%, respectively. Most AEs/SAEs were of mild or moderate severity; events related to venepuncture were most frequent (46.8%). The majority of withdrawals with known causes were due to non-medical reasons. After an initial drop, IgG levels remained stable for up to 10 years. ConclusionsThe results of this interim analysis showed no critical difference in donor safety between donors in an individualized program and those who donated according to current guidelines, supporting the concept of donor stratification by pre-donation IgG levels