Background: Source plasma (SP) is the primary starting material for 87% of plasma-derived medicinal products globally. Plasmavigilance is a program designed to collect, analyze, and monitor donor adverse events (AEs) across the SP collection industry. Donor retention depends on donors having a safe and satisfactory experience. This study analyzes AE rates and SP donor characteristics that may be predictors of an AE.
Study Design And Methods: Donation data for 1.1 million donors making 12,183,182 SP donations over a 4-month period were analyzed. This represented approximately 72% of the donations collected by the U.S. plasma industry. The Standard for Recording Donor Adverse Events was used for AE definitions and classifications.
Results: The overall AE rate was 15.85/10 donations. The two AEs with the highest rates were Hypotensive and Phlebotomy events (8.32 and 5.91/10 donations, respectively). Females had higher overall AE rates than males (25.76 vs. 9.85/10 donations), and first-time donors had higher overall AE rates than repeat donors (136.66 vs. 12.37/10 donations). Weight, body mass index, age, and pre-donation estimated blood volume also were predictors of AE.
Discussion: SP donors have low AE rates with 90% being events classified as Hypotensive or Phlebotomy. Special attention and mitigation strategies should be directed to donors who are young, lightweight (between 100 and 124 pounds), female, or first-time donors to further reduce the incidence of AE, continue to ensure the donor has a safe experience, and facilitate donor retention.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9291118 | PMC |
http://dx.doi.org/10.1111/trf.16612 | DOI Listing |
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