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.

Download full-text PDF

Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9291118PMC
http://dx.doi.org/10.1111/trf.16612DOI Listing

Publication Analysis

Top Keywords

source plasma
8
donors
8
donor adverse
8
adverse events
8
donor retention
8
hypotensive phlebotomy
8
higher rates
8
first-time donors
8
donor
6
donations
6

Similar Publications

Want AI Summaries of new PubMed Abstracts delivered to your In-box?

Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!