PMID- 35748490 OWN - NLM STAT- MEDLINE DCOM- 20220712 LR - 20230325 IS - 1537-2995 (Electronic) IS - 0041-1132 (Print) IS - 0041-1132 (Linking) VI - 62 IP - 7 DP - 2022 Jul TI - Comparative risk of pulmonary adverse events with transfusion of pathogen reduced and conventional platelet components. PG - 1365-1376 LID - 10.1111/trf.16987 [doi] AB - BACKGROUND: Platelet 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 DESIGN: An 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. RESULTS: By 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. DISCUSSION: PRPC demonstrated reduced TEAMV with no excess treatment-related pulmonary morbidity. CI - (c) 2022 Cerus Corporation. Transfusion published by Wiley Periodicals LLC on behalf of AABB. FAU - Snyder, Edward L AU - Snyder EL AD - Yale University School of Medicine, New Haven, Connecticut, USA. FAU - Wheeler, Allison P AU - Wheeler AP AUID- ORCID: 0000-0003-3967-4873 AD - Vanderbilt University Medical Center, Nashville, Tennessee, USA. FAU - Refaai, Majed AU - Refaai M AD - University of Rochester Medical Center, Rochester, New York, USA. FAU - Cohn, Claudia S AU - Cohn CS AUID- ORCID: 0000-0001-9847-0470 AD - University of Minnesota Medical Center, Minneapolis, Minnesota, USA. FAU - Poisson, Jessica AU - Poisson J AD - Duke University Medical Center, Durham, North Carolina, USA. FAU - Fontaine, Magali AU - Fontaine M AUID- ORCID: 0000-0001-6731-9516 AD - University of Maryland Medical Center, Baltimore, Maryland, USA. FAU - Sehl, Mary AU - Sehl M AD - UCLA Medical Center, Los Angeles, California, USA. FAU - Nooka, Ajay K AU - Nooka AK AD - Emory University Medical Center, Atlanta, Georgia, USA. FAU - Uhl, Lynne AU - Uhl L AD - Harvard University - Beth Israel Deaconess Hospital, Boston, Massachusetts, USA. FAU - Spinella, Philip AU - Spinella P AUID- ORCID: 0000-0003-1721-0541 AD - University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA. FAU - Fenelus, Maly AU - Fenelus M AD - Memorial-Sloan Kettering Medical Center, New York, New York, USA. FAU - Liles, Darla AU - Liles D AD - East Carolina University Medical Center, Greenville, North Carolina, USA. FAU - Coyle, Thomas AU - Coyle T AD - Trihealth Medical Center, Cincinnati, Ohio, USA. FAU - Becker, Joanne AU - Becker J AD - Roswell Park Medical Center, Buffalo, New York, USA. FAU - Jeng, Michael AU - Jeng M AD - Stanford Medical School, Palo Alto, California, USA. FAU - Gehrie, Eric A AU - Gehrie EA AUID- ORCID: 0000-0002-5354-3899 AD - Johns-Hopkins Medical Institute, Baltimore, Maryland, USA. FAU - Spencer, Bryan R AU - Spencer BR AUID- ORCID: 0000-0002-9008-9154 AD - American Red Cross Scientific Affairs, Dedham, Massachusetts, USA. FAU - Young, Pampee AU - Young P AUID- ORCID: 0000-0001-5313-0376 AD - Vanderbilt University Medical Center, Nashville, Tennessee, USA. FAU - Johnson, Andrew AU - Johnson A AD - University of Minnesota Medical Center, Minneapolis, Minnesota, USA. FAU - O'Brien, Jennifer J AU - O'Brien JJ AD - Mayo Clinic Florida, Jacksonville, Florida, USA. FAU - Schiller, Gary J AU - Schiller GJ AD - UCLA Medical Center, Los Angeles, California, USA. FAU - Roback, John D AU - Roback JD AD - Emory University Medical Center, Atlanta, Georgia, USA. FAU - Malynn, Elizabeth AU - Malynn E AD - Harvard University - Beth Israel Deaconess Hospital, Boston, Massachusetts, USA. FAU - Jackups, Ronald AU - Jackups R AD - Washington University St. Louis, St. Louis, Missouri, USA. FAU - Avecilla, Scott T AU - Avecilla ST AUID- ORCID: 0000-0003-0661-9704 AD - Memorial-Sloan Kettering Medical Center, New York, New York, USA. FAU - Lin, Jin-Sying AU - Lin JS AD - Cerus Corporation, Concord, California, USA. FAU - Liu, Kathy AU - Liu K AD - Cerus Corporation, Concord, California, USA. FAU - Bentow, Stanley AU - Bentow S AD - Cerus Corporation, Concord, California, USA. FAU - Peng, Ho-Lan AU - Peng HL AD - Cerus Corporation, Concord, California, USA. FAU - Varrone, Jeanne AU - Varrone J AD - Cerus Corporation, Concord, California, USA. FAU - Benjamin, Richard J AU - Benjamin RJ AUID- ORCID: 0000-0001-6618-4744 AD - Cerus Corporation, Concord, California, USA. FAU - Corash, Laurence M AU - Corash LM AUID- ORCID: 0000-0002-8615-9869 AD - Cerus Corporation, Concord, California, USA. LA - eng GR - P30 CA008748/CA/NCI NIH HHS/United States GR - UL1 TR001863/TR/NCATS NIH HHS/United States PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20220624 PL - United States TA - Transfusion JT - Transfusion JID - 0417360 RN - 0 (Photosensitizing Agents) SB - IM MH - Blood Platelets MH - Blood Transfusion MH - Cohort Studies MH - Humans MH - Photosensitizing Agents MH - Platelet Transfusion/adverse effects MH - *Respiratory Distress Syndrome/etiology/therapy MH - *Transfusion Reaction/epidemiology/etiology PMC - PMC9544211 OTO - NOTNLM OT - assisted mechanical ventilation OT - pathogen reduction OT - platelet transfusion OT - pulmonary adverse events COIS- Edward L. Snyder, Allison P Wheeler, Majed Refaai, Claudia S. Cohn, Jessica Poisson, Magali Fontaine, Mary Sehl, Ajay K. Nooka, Lynne Uhl, Philip Spinella, Maly Fenelus, Darla Liles, Thomas Coyle, Joanne Becker, Michael Jeng, Eric A. Gehrie, Bryan R. Spencer, Pampee Young, Andrew Johnson, Jennifer J. O'Brien, Gary J. Schiller, John D. Roback, Elizabeth Malynn, Ronald Jackups, and Scott T. Avecilla have no personal conflicts of interest. They served as study investigators and were compensated through their respective institutional research contracts with Cerus Corporation. Jin-Sying Lin, Kathy Liu, Stanley Bentow, and Ho-Lan Peng are employees of Cerus Corporation, the study sponsor, and received compensation and equity options as part of their employment. Jeanne Varrone, Richard J. Benjamin, and Laurence M. Corash are employees of Cerus Corporation, the study sponsor, and received compensation and equity options as part of their employment. EDAT- 2022/06/25 06:00 MHDA- 2022/07/14 06:00 PMCR- 2022/10/07 CRDT- 2022/06/24 07:03 PHST- 2022/05/03 00:00 [revised] PHST- 2022/03/23 00:00 [received] PHST- 2022/05/10 00:00 [accepted] PHST- 2022/06/25 06:00 [pubmed] PHST- 2022/07/14 06:00 [medline] PHST- 2022/06/24 07:03 [entrez] PHST- 2022/10/07 00:00 [pmc-release] AID - TRF16987 [pii] AID - 10.1111/trf.16987 [doi] PST - ppublish SO - Transfusion. 2022 Jul;62(7):1365-1376. doi: 10.1111/trf.16987. Epub 2022 Jun 24.