(P-TS-5) Adverse Event Outcomes of 6-Day-Stored Pathogen-Reduced Platelet Transfusion

Background/Case Studies: Platelet concentrates (PCs) are heavily transfused blood products with high inventory turnover and short shelf life. Shortages due to supply-chain disruption or local high-volume use threaten availability for active bleeding or prophylactic indications. Pathogen-reduced platelet concentrates (PRPCs) have been treated to inactivate pathogens, reducing the risk of transfusion transmitted infections (TTIs). In the United States (US), PRPCs are licensed for 5 days. Several countries have licensed the PRPCs for up to 7 days, and reports detail no significant increase in adverse events and limited impacts to efficacy. We report observed adverse event rates at a US-based, tertiary academic medical center that extended the expiration dates of PRPCs by 24h (off-label) during times of severe shortage and/or unexpected high-volume use.

Study

Design/Methods: Donation identification numbers (DINs) of all PRPC transfusion events that occurred at our center from March 2020 to March 2023 were cross-referenced with those recorded in variance reports of expiration date extensions for all PCs in inventory. To determine adverse event rates, DINs associated with any transfusion reaction (excluding delayed serologic transfusion reactions) associated with PRPC transfusion during the study period were also extracted. Relative risk was calculated, and any-cause transfusion reaction incidences between groups were compared statistically via Fisher’s exact test. Total and specific reaction incidences were compared to those previously reported from 2010 to 2018 via the CDC National Healthcare Safety Network’s Hemovigilance Module.

Results/Findings: Among 31,076 PRPCs transfused, 1881 (6.05%) extended expiration date products were administered. Of these, 17 extended PRPCs were implicated in transfusion reactions (0.904% incidence), compared to 220 (0.754% incidence) in the non-extended group. The relative risk of any-cause transfusion reaction following extended PRPC transfusion was 1.199 (95% CI = 0.7369 to 1.948) compared to standard-storage PRPC transfusion; no significant difference in any-cause transfusion reaction risk was detected (p > 0.4921) as a result of transfusion beyond the licensed storage period. Specific reaction rates for the extended PRPC group were comparable to previously reported national rates for PRPCs. No TTIs were observed in either group.

Conclusions: Transfusion of 24h-extended PRPCs did not result in significantly increased reports of any-cause transfusion reaction. PRPC expiration extension may provide a useful strategy for increasing PC availability in times of shortage or unexpected high-volume use.

Importance of research: Platelet concentrates (PCs) are difficult blood components for hospital blood banks to procure. Pathogen-reduced PCs (PRPCs) have been approved for 7-day storage by several countries; however, only 5 days of storage are licensed in the US. This study compares the incidence of transfusion reactions to 6-day-stored PRPCs (off-label) vs PRPCs stored for the licensed period at a US institution.