Comparative risk of pulmonary adverse events with transfusion of pathogen reduced and conventional platelet components

Edward L Snyder¹, Allison P Wheeler², Majed Refaai³, Claudia S Cohn⁴, Jessica Poisson⁵, Magali Fontaine⁶, Mary Sehl⁷, Ajay K Nooka⁸, Lynne Uhl⁹, Philip Spinella¹⁰, Maly Fenelus¹¹, Darla Liles¹², Thomas Coyle¹³, Joanne Becker¹⁴, Michael Jeng¹⁵, Eric A Gehrie¹⁶, Bryan R Spencer¹⁷, Pampee Young², Andrew Johnson⁴, Jennifer J O'Brien¹⁸, Gary J Schiller⁷, John D Roback⁸, Elizabeth Malynn⁹, Ronald Jackups¹⁹, Scott T Avecilla¹¹, Jin-Sying Lin²⁰, Kathy Liu²⁰, Stanley Bentow²⁰, Ho-Lan Peng²⁰, Jeanne Varrone²⁰, Richard J Benjamin²⁰, Laurence M Corash²⁰

Affiliations

¹ Yale University School of Medicine, New Haven, Connecticut, USA.
² Vanderbilt University Medical Center, Nashville, Tennessee, USA.
³ University of Rochester Medical Center, Rochester, New York, USA.
⁴ University of Minnesota Medical Center, Minneapolis, Minnesota, USA.
⁵ Duke University Medical Center, Durham, North Carolina, USA.
⁶ University of Maryland Medical Center, Baltimore, Maryland, USA.
⁷ UCLA Medical Center, Los Angeles, California, USA.
⁸ Emory University Medical Center, Atlanta, Georgia, USA.
⁹ Harvard University - Beth Israel Deaconess Hospital, Boston, Massachusetts, USA.
¹⁰ University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.
¹¹ Memorial-Sloan Kettering Medical Center, New York, New York, USA.
¹² East Carolina University Medical Center, Greenville, North Carolina, USA.
¹³ Trihealth Medical Center, Cincinnati, Ohio, USA.
¹⁴ Roswell Park Medical Center, Buffalo, New York, USA.
¹⁵ Stanford Medical School, Palo Alto, California, USA.
¹⁶ Johns-Hopkins Medical Institute, Baltimore, Maryland, USA.
¹⁷ American Red Cross Scientific Affairs, Dedham, Massachusetts, USA.
¹⁸ Mayo Clinic Florida, Jacksonville, Florida, USA.
¹⁹ Washington University St. Louis, St. Louis, Missouri, USA.
²⁰ Cerus Corporation, Concord, California, USA.

PMID: 35748490
PMCID: PMC9544211
DOI: 10.1111/trf.16987

Comparative risk of pulmonary adverse events with transfusion of pathogen reduced and conventional platelet components

Edward L Snyder et al. Transfusion. 2022 Jul.

. 2022 Jul;62(7):1365-1376.

doi: 10.1111/trf.16987. Epub 2022 Jun 24.

Authors

Affiliations

¹ Yale University School of Medicine, New Haven, Connecticut, USA.
² Vanderbilt University Medical Center, Nashville, Tennessee, USA.
³ University of Rochester Medical Center, Rochester, New York, USA.
⁴ University of Minnesota Medical Center, Minneapolis, Minnesota, USA.
⁵ Duke University Medical Center, Durham, North Carolina, USA.
⁶ University of Maryland Medical Center, Baltimore, Maryland, USA.
⁷ UCLA Medical Center, Los Angeles, California, USA.
⁸ Emory University Medical Center, Atlanta, Georgia, USA.
⁹ Harvard University - Beth Israel Deaconess Hospital, Boston, Massachusetts, USA.
¹⁰ University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.
¹¹ Memorial-Sloan Kettering Medical Center, New York, New York, USA.
¹² East Carolina University Medical Center, Greenville, North Carolina, USA.
¹³ Trihealth Medical Center, Cincinnati, Ohio, USA.
¹⁴ Roswell Park Medical Center, Buffalo, New York, USA.
¹⁵ Stanford Medical School, Palo Alto, California, USA.
¹⁶ Johns-Hopkins Medical Institute, Baltimore, Maryland, USA.
¹⁷ American Red Cross Scientific Affairs, Dedham, Massachusetts, USA.
¹⁸ Mayo Clinic Florida, Jacksonville, Florida, USA.
¹⁹ Washington University St. Louis, St. Louis, Missouri, USA.
²⁰ Cerus Corporation, Concord, California, USA.

PMID: 35748490
PMCID: PMC9544211
DOI: 10.1111/trf.16987

Abstract

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.

Keywords: assisted mechanical ventilation; pathogen reduction; platelet transfusion; pulmonary adverse events.

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Conflict of interest statement

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.

Figures

**FIGURE 1**
Distribution of the number of platelet components transfused for the per protocol analysis (blue— conventional PC, red—PRPC) [Color figure can be viewed at wileyonlinelibrary.com]

**FIGURE 2**
Cumulative incidence of TEAMV for conventional PC and PRPC. HR and 95% CIs were estimated from Cox proportional hazards regression. [Color figure can be viewed at wileyonlinelibrary.com]

**FIGURE 3**
The relative risk of TEAMV for recipients of PRPC compared with conventional PC. Risk of TEAMV was reduced for recipients of PRPC <65 years of age, male sex, non‐white race, primary therapy with chemotherapy without HCT, history of pulmonary disease, and history of cardiac disease. p‐values were based on the Breslow–day test for homogeneous odds ratios across subgroups [Color figure can be viewed at wileyonlinelibrary.com]

See this image and copyright information in PMC

References

1. U.S. Department of Health and Human Services Food and Drug Administration . Bacterial risk control strategies for blood collection establishments and transfusion services to enhance the safety and availability of platelets for transfusion: draft guidance for industry. Center for biologics evaluation and research. Silver Spring, MD: U.S. Department of Health and Human Services Food and Drug Administration; 2016.
1. McCullough J, Vesole DH, Benjamin RJ, Slichter SJ, Pineda A, Snyder E, et al. Therapeutic efficacy and safety of platelets treated with a photochemical process for pathogen inactivation: the SPRINT trial. Blood. 2004;104:1534–41. - PubMed
1. Snyder E, McCullough J, Slichter SJ, Strauss RG, Lopez‐Plaza I, Lin JS, et al. Clinical safety of platelets photochemically treated with amotosalen HCl and ultraviolet a light for pathogen inactivation: the SPRINT trial. Transfusion. 2005;45:1864–75. - PubMed
1. Corash L, Lin JS, Sherman CD, Eiden J. Determination of acute lung injury after repeated platelet transfusions. Blood. 2011;117:1014–20. - PubMed
1. Matthay MA, Zemans RL, Zimmerman GA, Arabi YM, Beitler JR, Mercat A, et al. Acute respiratory distress syndrome. Nat Rev Dis Primers. 2019;5:18. - PMC - PubMed

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Comparative risk of pulmonary adverse events with transfusion of pathogen reduced and conventional platelet components

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Comparative risk of pulmonary adverse events with transfusion of pathogen reduced and conventional platelet components

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