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

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; Scott T. Avecilla; Jin Sying Lin; Kathy Liu; Stanley Bentow; Ho Lan Peng; Jeanne Varrone; Richard J. Benjamin; Laurence M. Corash

doi:10.1111/trf.16987

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

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'BrienGary J. Schiller, John D. Roback, Elizabeth Malynn, Ronald Jackups, Scott T. Avecilla, Jin Sying Lin, Kathy Liu, Stanley Bentow, Ho Lan Peng, Jeanne Varrone, Richard J. Benjamin, Laurence M. Corash

Laboratory Medicine and Pathology

Research output: Contribution to journal › Article › peer-review

3 Scopus citations

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.

Original language	English (US)
Pages (from-to)	1365-1376
Number of pages	12
Journal	Transfusion
Volume	62
Issue number	7
DOIs	https://doi.org/10.1111/trf.16987
State	Published - Jul 2022

Bibliographical note

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.

Keywords

assisted mechanical ventilation
pathogen reduction
platelet transfusion
pulmonary adverse events

PubMed: MeSH publication types

Journal Article
Research Support, Non-U.S. Gov't

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10.1111/trf.16987

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Snyder, E. L., Wheeler, A. P., Refaai, M., Cohn, C. S., Poisson, J., Fontaine, M., Sehl, M., Nooka, A. K., Uhl, L., Spinella, P., Fenelus, M., Liles, D., Coyle, T., Becker, J., Jeng, M., Gehrie, E. A., Spencer, B. R., Young, P., Johnson, A., ... Corash, L. M. (2022). Comparative risk of pulmonary adverse events with transfusion of pathogen reduced and conventional platelet components. Transfusion, 62(7), 1365-1376. https://doi.org/10.1111/trf.16987

Snyder, EL, Wheeler, AP, Refaai, M, Cohn, CS, Poisson, J, Fontaine, M, Sehl, M, Nooka, AK, Uhl, L, Spinella, P, Fenelus, M, Liles, D, Coyle, T, Becker, J, Jeng, M, Gehrie, EA, Spencer, BR, Young, P, Johnson, A, O'Brien, JJ, Schiller, GJ, Roback, JD, Malynn, E, Jackups, R, Avecilla, ST, Lin, JS, Liu, K, Bentow, S, Peng, HL, Varrone, J, Benjamin, RJ & Corash, LM 2022, 'Comparative risk of pulmonary adverse events with transfusion of pathogen reduced and conventional platelet components', Transfusion, vol. 62, no. 7, pp. 1365-1376. https://doi.org/10.1111/trf.16987

@article{194619b4f19a4e5394403ff81870a29f,

title = "Comparative risk of pulmonary adverse events with transfusion of pathogen reduced and conventional platelet components",

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",

author = "Snyder, {Edward L.} and Wheeler, {Allison P.} and Majed Refaai and Cohn, {Claudia S.} and Jessica Poisson and Magali Fontaine and Mary Sehl and Nooka, {Ajay K.} and Lynne Uhl and Philip Spinella and Maly Fenelus and Darla Liles and Thomas Coyle and Joanne Becker and Michael Jeng and Gehrie, {Eric A.} and Spencer, {Bryan R.} and Pampee Young and Andrew Johnson and O'Brien, {Jennifer J.} and Schiller, {Gary J.} and Roback, {John D.} and Elizabeth Malynn and Ronald Jackups and Avecilla, {Scott T.} and Lin, {Jin Sying} and Kathy Liu and Stanley Bentow and Peng, {Ho Lan} and Jeanne Varrone and Benjamin, {Richard J.} and Corash, {Laurence M.}",

note = "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: {\textcopyright} 2022 Cerus Corporation. Transfusion published by Wiley Periodicals LLC on behalf of AABB.",

year = "2022",

month = jul,

doi = "10.1111/trf.16987",

language = "English (US)",

volume = "62",

pages = "1365--1376",

journal = "Transfusion",

issn = "0041-1132",

publisher = "Wiley-Blackwell",

number = "7",

}

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

Abstract

Bibliographical note

Keywords

PubMed: MeSH publication types

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