Cerus Corporation, Concord, CA, USA Concord, California, United States
Background/Case Studies: Amotosalen/UVA pathogen reduced (APR) platelets (PLTs) and plasma (PLS) were approved in Europe in 2002 and 2006 to reduce the risk of transfusion-transmitted infections and replace irradiation to prevent TA-GVHD. Between 2003-16, Cerus Corporation collected real world evidence (RWE) on the safety of 21,548 APR PLTs in 4,765 patients, and 57,428 APR PLS components in 9,813 patients in 11 countries. Cerus initiated a new cross-sectional study in Europe in 2019 to collect RWE on the nature, frequency and severity of transfusion reactions (TRs) in patients transfused with APR PLTs and/or PLS in centers using APR.
Study
Design/Methods: Observational data were captured prospectively from routine blood bank records at transfusion centers in Graz, Austria, Warsaw, Poland, and Bari, Italy. Patient consent was not required for this single-arm, non-interventional study. Demographic information (sex, age), unit descriptions (e.g., collection method) and TRs were captured for all patients transfused in selected wards during defined surveillance periods. De-identified patient data were stratified by sex, age and diagnosis. TRs were identified by physicians using ISBT definitions and routine hospital reporting systems. Descriptive statistics were calculated.
Results/Findings: A total of 3,425 APR PLT and 1,907 APR PLS components were transfused to 475 and 87 patients, respectively, between December 2019 and March 2025. 50.4% of patients were female; 36.8% were ≥65 years. All units were leukocyte reduced; none were irradiated or CMV tested. Surveillance periods ranged from 1-6 months; Graz and Warsaw completed multiple periods. Apheresis accounted for 44% of PLTs in Graz, 93% in Warsaw, and 11% in Bari; the remainder were pooled. All PLS in Graz and 52% in Warsaw were apheresis. All PLTs in Graz and Bari, and 76% in Warsaw were suspended in platelet additive solution. PLT shelf-life was 7 days in all sites: 71% were transfused on days 2-5 post-collection; ~20% on day 7. 1% of PCs in Warsaw were locally approved for cryopreservation and transfused after day 7. PLT doses averaged 3.0 x 1011 (mean range: 2.6-3.4). Patients received a mean of 7.2 PLTs (range: 1-91) and 21.9 PLS (range: 1-294). Six PLT TRs (0.18% of PLTs) were reported in Graz and Warsaw: 3 FNHTR, 2 allergic and 1 transfusion-associated dyspnea. Two PLS TRs (allergic, unclassified) were reported in Warsaw (0.10% of PLS units) (Table). TRs were non-serious and moderate in severity; all patients recovered. TR rates were comparable to historical rates for conventional PCs at all sites and lower than rates (~1%) in prior studies. Conclusions: Cross-sectional studies allow hospitals and manufacturers to monitor and reaffirm APR PLT and PLS benefit-risk profiles with RWE.
