학술논문
Comparative risk of pulmonary adverse events with transfusion of pathogen reduced and conventional platelet components
Document Type
article
Author
Snyder, Edward L; Wheeler, Allison P; Refaai, Majed; Cohn, Claudia S; Poisson, Jessica; Fontaine, Magali; Sehl, Mary; Nooka, Ajay K; Uhl, Lynne; Spinella, Philip; Fenelus, Maly; Liles, Darla; Coyle, Thomas; Becker, Joanne; Jeng, Michael; Gehrie, Eric A; Spencer, Bryan R; Young, Pampee; Johnson, Andrew; O'Brien, Jennifer J; Schiller, Gary J; Roback, John D; Malynn, Elizabeth; Jackups, Ronald; Avecilla, Scott T; Lin, Jin‐Sying; Liu, Kathy; Bentow, Stanley; Peng, Ho‐Lan; Varrone, Jeanne; Benjamin, Richard J; Corash, Laurence M
Source
Transfusion. 62(7)
Subject
Language
Abstract
BackgroundPlatelet transfusion carries risk of transfusion-transmitted infection (TTI). Pathogen reduction of platelet components (PRPC) is designed to reduce TTI. Pulmonary adverse events (AEs), including transfusion-related acute lung injury and acute respiratory distress syndrome (ARDS) occur with platelet transfusion.Study designAn open label, sequential cohort study of transfusion-dependent hematology-oncology patients was conducted to compare pulmonary safety of PRPC with conventional PC (CPC). The primary outcome was the incidence of treatment-emergent assisted mechanical ventilation (TEAMV) by non-inferiority. Secondary outcomes included: time to TEAMV, ARDS, pulmonary AEs, peri-transfusion AE, hemorrhagic AE, transfusion reactions (TRs), PC and red blood cell (RBC) use, and mortality.ResultsBy modified intent-to-treat (mITT), 1068 patients received 5277 PRPC and 1223 patients received 5487 CPC. The cohorts had similar demographics, primary disease, and primary therapy. PRPC were non-inferior to CPC for TEAMV (treatment difference -1.7%, 95% CI: (-3.3% to -0.1%); odds ratio = 0.53, 95% CI: (0.30, 0.94). The cumulative incidence of TEAMV for PRPC (2.9%) was significantly less than CPC (4.6%, p = .039). The incidence of ARDS was less, but not significantly different, for PRPC (1.0% vs. 1.8%, p = .151; odds ratio = 0.57, 95% CI: (0.27, 1.18). AE, pulmonary AE, and mortality were not different between cohorts. TRs were similar for PRPC and CPC (8.3% vs. 9.7%, p = .256); and allergic TR were significantly less with PRPC (p = .006). PC and RBC use were not increased with PRPC.DiscussionPRPC demonstrated reduced TEAMV with no excess treatment-related pulmonary morbidity.