TY - JOUR
T1 - Comparative risk of pulmonary adverse events with transfusion of pathogen reduced and conventional platelet components
AU - Snyder, Edward L.
AU - Wheeler, Allison P.
AU - Refaai, Majed
AU - Cohn, Claudia S.
AU - Poisson, Jessica
AU - Fontaine, Magali
AU - Sehl, Mary
AU - Nooka, Ajay K.
AU - Uhl, Lynne
AU - Spinella, Philip
AU - Fenelus, Maly
AU - Liles, Darla
AU - Coyle, Thomas
AU - Becker, Joanne
AU - Jeng, Michael
AU - Gehrie, Eric A.
AU - Spencer, Bryan R.
AU - Young, Pampee
AU - Johnson, Andrew
AU - O'Brien, Jennifer J.
AU - Schiller, Gary J.
AU - Roback, John D.
AU - Malynn, Elizabeth
AU - Jackups, Ronald
AU - Avecilla, Scott T.
AU - Lin, Jin Sying
AU - Liu, Kathy
AU - Bentow, Stanley
AU - Peng, Ho Lan
AU - Varrone, Jeanne
AU - Benjamin, Richard J.
AU - Corash, Laurence M.
N1 - Funding Information:
The authors acknowledge the substantial contribution to the study by the pulmonary expert panel: Chairman, Ednan Bajwa, MD, MPH, Roy Brower, MD, Todd Rice, MD, MSc, and Boyd Taylor Thompson, MD. Staff at the study site blood centers provided study platelet components to enable the study. Therese Chlebeck provided additional support for the study at the University of Minnesota.
Publisher Copyright:
© 2022 Cerus Corporation. Transfusion published by Wiley Periodicals LLC on behalf of AABB.
PY - 2022/7
Y1 - 2022/7
N2 - 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.
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.
KW - assisted mechanical ventilation
KW - pathogen reduction
KW - platelet transfusion
KW - pulmonary adverse events
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U2 - 10.1111/trf.16987
DO - 10.1111/trf.16987
M3 - Article
C2 - 35748490
AN - SCOPUS:85132592666
SN - 0041-1132
VL - 62
SP - 1365
EP - 1376
JO - Transfusion
JF - Transfusion
IS - 7
ER -