Affiliation:
1. Scientific and Medical Affairs Cerus Corporation Concord California USA
2. Scientific Affairs Cerus BV Amersfoort Netherlands
3. Biostatistics and Data Management Cerus Corporation Concord California USA
Abstract
AbstractBackgroundFrance converted to universal pathogen reduced (PR; amotosalen/UVA) platelets in 2017 and extended platelet component (PC) shelf‐life from 5‐ to 7‐days in 2018 and 2019. Annual national hemovigilance (HV) reports characterized longitudinal PC utilization and safety over 11 years, including several years prior to PR adoption as the national standard of care.MethodsData were extracted from published annual HV reports. Apheresis and pooled buffy coat [BC] PC use was compared. Transfusion reactions (TRs) were stratified by type, severity, and causality. Trends were assessed for three periods: Baseline (2010–14; ~7% PR), Period 1 ([P1] 2015–17; 8%–21% PR), and Period 2 ([P2] 2018–20; 100% PR).ResultsPC use increased by 19.1% between 2010 and 2020. Pooled BC PC production increased from 38.8% to 68.2% of total PCs. Annual changes in PCs issued averaged 2.4% per year at baseline, −0.02% (P1) and 2.8% (P2). The increase in P2 coincided with a reduction in the target platelet dose and extension to 7‐day storage. Allergic reactions, alloimmunization, febrile non‐hemolytic TRs, immunologic incompatibility, and ineffective transfusions accounted for >90% of TRs. Overall, TR incidence per 100,000 PCs issued declined from 527.9 (2010) to 345.7 (2020). Severe TR rates declined 34.8% between P1‐P2. Forty‐six transfusion‐transmitted bacterial infections (TTBI) were associated with conventional PCs during baseline and P1. No TTBI were associated with amotosalen/UVA PCs. Infections with Hepatitis E (HEV) a non‐enveloped virus resistant to PR, were reported in all periods.DiscussionLongitudinal HV analysis demonstrated stable PC utilization trends with reduced patient risk during conversion to universal 7‐day amotosalen/UVA PCs.
Subject
Hematology,Immunology,Immunology and Allergy
Cited by
2 articles.
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