Pragmatic Randomized Optimal Platelet and Plasma Ratios (PROPPR) Trial

Design, rationale and implementation

Sarah Baraniuk, Barbara C. Tilley, Deborah J. Del Junco, Erin E. Fox, Gerald Van Belle, Charles E. Wade, Jeanette M. Podbielski, Angela M. Beeler, John R. Hess, Eileen M. Bulger, Martin Schreiber, Kenji Inaba, Timothy C. Fabian, Jeffrey D. Kerby, Mitchell Jay Cohen, Christopher N. Miller, Sandro Rizoli, Thomas M. Scalea, Terence O'Keeffe, Karen Brasel & 3 others Bryan A. Cotton, Peter Muskat, John B. Holcomb

    Research output: Contribution to journalArticle

    66 Citations (Scopus)

    Abstract

    Background Forty percent of in-hospital deaths among injured patients involve massive truncal haemorrhage. These deaths may be prevented with rapid haemorrhage control and improved resuscitation techniques. The Pragmatic Randomized Optimal Platelet and Plasma Ratios (PROPPR) Trial was designed to determine if there is a difference in mortality between subjects who received different ratios of FDA approved blood products. This report describes the design and implementation of PROPPR. Study Design PROPPR was designed as a randomized, two-group, Phase III trial conducted in subjects with the highest level of trauma activation and predicted to have a massive transfusion. Subjects at 12 North American level 1 trauma centres were randomized into one of two standard transfusion ratio interventions: 1:1:1 or 1:1:2, (plasma, platelets, and red blood cells). Clinical data and serial blood samples were collected under Exception from Informed Consent (EFIC) regulations. Co-primary mortality endpoints of 24 h and 30 days were evaluated. Results Between August 2012 and December 2013, 680 patients were randomized. The overall median time from admission to randomization was 26 min. PROPPR enrolled at higher than expected rates with fewer than expected protocol deviations. Conclusion PROPPR is the largest randomized study to enrol severely bleeding patients. This study showed that rapidly enrolling and successfully providing randomized blood products to severely injured patients in an EFIC study is feasible. PROPPR was able to achieve these goals by utilizing a collaborative structure and developing successful procedures and design elements that can be part of future trauma studies.

    Original languageEnglish (US)
    Pages (from-to)1287-1295
    Number of pages9
    JournalInjury
    Volume45
    Issue number9
    DOIs
    StatePublished - 2014

    Fingerprint

    Blood Platelets
    Hemorrhage
    Informed Consent
    Mortality
    Trauma Centers
    Wounds and Injuries
    Random Allocation
    Resuscitation
    Erythrocytes

    Keywords

    • Clinical trial
    • Plasma
    • Platelets
    • Resuscitation
    • Transfusion
    • Trauma

    ASJC Scopus subject areas

    • Orthopedics and Sports Medicine
    • Emergency Medicine

    Cite this

    Baraniuk, S., Tilley, B. C., Del Junco, D. J., Fox, E. E., Van Belle, G., Wade, C. E., ... Holcomb, J. B. (2014). Pragmatic Randomized Optimal Platelet and Plasma Ratios (PROPPR) Trial: Design, rationale and implementation. Injury, 45(9), 1287-1295. https://doi.org/10.1016/j.injury.2014.06.001

    Pragmatic Randomized Optimal Platelet and Plasma Ratios (PROPPR) Trial : Design, rationale and implementation. / Baraniuk, Sarah; Tilley, Barbara C.; Del Junco, Deborah J.; Fox, Erin E.; Van Belle, Gerald; Wade, Charles E.; Podbielski, Jeanette M.; Beeler, Angela M.; Hess, John R.; Bulger, Eileen M.; Schreiber, Martin; Inaba, Kenji; Fabian, Timothy C.; Kerby, Jeffrey D.; Cohen, Mitchell Jay; Miller, Christopher N.; Rizoli, Sandro; Scalea, Thomas M.; O'Keeffe, Terence; Brasel, Karen; Cotton, Bryan A.; Muskat, Peter; Holcomb, John B.

    In: Injury, Vol. 45, No. 9, 2014, p. 1287-1295.

    Research output: Contribution to journalArticle

    Baraniuk, S, Tilley, BC, Del Junco, DJ, Fox, EE, Van Belle, G, Wade, CE, Podbielski, JM, Beeler, AM, Hess, JR, Bulger, EM, Schreiber, M, Inaba, K, Fabian, TC, Kerby, JD, Cohen, MJ, Miller, CN, Rizoli, S, Scalea, TM, O'Keeffe, T, Brasel, K, Cotton, BA, Muskat, P & Holcomb, JB 2014, 'Pragmatic Randomized Optimal Platelet and Plasma Ratios (PROPPR) Trial: Design, rationale and implementation', Injury, vol. 45, no. 9, pp. 1287-1295. https://doi.org/10.1016/j.injury.2014.06.001
    Baraniuk, Sarah ; Tilley, Barbara C. ; Del Junco, Deborah J. ; Fox, Erin E. ; Van Belle, Gerald ; Wade, Charles E. ; Podbielski, Jeanette M. ; Beeler, Angela M. ; Hess, John R. ; Bulger, Eileen M. ; Schreiber, Martin ; Inaba, Kenji ; Fabian, Timothy C. ; Kerby, Jeffrey D. ; Cohen, Mitchell Jay ; Miller, Christopher N. ; Rizoli, Sandro ; Scalea, Thomas M. ; O'Keeffe, Terence ; Brasel, Karen ; Cotton, Bryan A. ; Muskat, Peter ; Holcomb, John B. / Pragmatic Randomized Optimal Platelet and Plasma Ratios (PROPPR) Trial : Design, rationale and implementation. In: Injury. 2014 ; Vol. 45, No. 9. pp. 1287-1295.
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    abstract = "Background Forty percent of in-hospital deaths among injured patients involve massive truncal haemorrhage. These deaths may be prevented with rapid haemorrhage control and improved resuscitation techniques. The Pragmatic Randomized Optimal Platelet and Plasma Ratios (PROPPR) Trial was designed to determine if there is a difference in mortality between subjects who received different ratios of FDA approved blood products. This report describes the design and implementation of PROPPR. Study Design PROPPR was designed as a randomized, two-group, Phase III trial conducted in subjects with the highest level of trauma activation and predicted to have a massive transfusion. Subjects at 12 North American level 1 trauma centres were randomized into one of two standard transfusion ratio interventions: 1:1:1 or 1:1:2, (plasma, platelets, and red blood cells). Clinical data and serial blood samples were collected under Exception from Informed Consent (EFIC) regulations. Co-primary mortality endpoints of 24 h and 30 days were evaluated. Results Between August 2012 and December 2013, 680 patients were randomized. The overall median time from admission to randomization was 26 min. PROPPR enrolled at higher than expected rates with fewer than expected protocol deviations. Conclusion PROPPR is the largest randomized study to enrol severely bleeding patients. This study showed that rapidly enrolling and successfully providing randomized blood products to severely injured patients in an EFIC study is feasible. PROPPR was able to achieve these goals by utilizing a collaborative structure and developing successful procedures and design elements that can be part of future trauma studies.",
    keywords = "Clinical trial, Plasma, Platelets, Resuscitation, Transfusion, Trauma",
    author = "Sarah Baraniuk and Tilley, {Barbara C.} and {Del Junco}, {Deborah J.} and Fox, {Erin E.} and {Van Belle}, Gerald and Wade, {Charles E.} and Podbielski, {Jeanette M.} and Beeler, {Angela M.} and Hess, {John R.} and Bulger, {Eileen M.} and Martin Schreiber and Kenji Inaba and Fabian, {Timothy C.} and Kerby, {Jeffrey D.} and Cohen, {Mitchell Jay} and Miller, {Christopher N.} and Sandro Rizoli and Scalea, {Thomas M.} and Terence O'Keeffe and Karen Brasel and Cotton, {Bryan A.} and Peter Muskat and Holcomb, {John B.}",
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    T1 - Pragmatic Randomized Optimal Platelet and Plasma Ratios (PROPPR) Trial

    T2 - Design, rationale and implementation

    AU - Baraniuk, Sarah

    AU - Tilley, Barbara C.

    AU - Del Junco, Deborah J.

    AU - Fox, Erin E.

    AU - Van Belle, Gerald

    AU - Wade, Charles E.

    AU - Podbielski, Jeanette M.

    AU - Beeler, Angela M.

    AU - Hess, John R.

    AU - Bulger, Eileen M.

    AU - Schreiber, Martin

    AU - Inaba, Kenji

    AU - Fabian, Timothy C.

    AU - Kerby, Jeffrey D.

    AU - Cohen, Mitchell Jay

    AU - Miller, Christopher N.

    AU - Rizoli, Sandro

    AU - Scalea, Thomas M.

    AU - O'Keeffe, Terence

    AU - Brasel, Karen

    AU - Cotton, Bryan A.

    AU - Muskat, Peter

    AU - Holcomb, John B.

    PY - 2014

    Y1 - 2014

    N2 - Background Forty percent of in-hospital deaths among injured patients involve massive truncal haemorrhage. These deaths may be prevented with rapid haemorrhage control and improved resuscitation techniques. The Pragmatic Randomized Optimal Platelet and Plasma Ratios (PROPPR) Trial was designed to determine if there is a difference in mortality between subjects who received different ratios of FDA approved blood products. This report describes the design and implementation of PROPPR. Study Design PROPPR was designed as a randomized, two-group, Phase III trial conducted in subjects with the highest level of trauma activation and predicted to have a massive transfusion. Subjects at 12 North American level 1 trauma centres were randomized into one of two standard transfusion ratio interventions: 1:1:1 or 1:1:2, (plasma, platelets, and red blood cells). Clinical data and serial blood samples were collected under Exception from Informed Consent (EFIC) regulations. Co-primary mortality endpoints of 24 h and 30 days were evaluated. Results Between August 2012 and December 2013, 680 patients were randomized. The overall median time from admission to randomization was 26 min. PROPPR enrolled at higher than expected rates with fewer than expected protocol deviations. Conclusion PROPPR is the largest randomized study to enrol severely bleeding patients. This study showed that rapidly enrolling and successfully providing randomized blood products to severely injured patients in an EFIC study is feasible. PROPPR was able to achieve these goals by utilizing a collaborative structure and developing successful procedures and design elements that can be part of future trauma studies.

    AB - Background Forty percent of in-hospital deaths among injured patients involve massive truncal haemorrhage. These deaths may be prevented with rapid haemorrhage control and improved resuscitation techniques. The Pragmatic Randomized Optimal Platelet and Plasma Ratios (PROPPR) Trial was designed to determine if there is a difference in mortality between subjects who received different ratios of FDA approved blood products. This report describes the design and implementation of PROPPR. Study Design PROPPR was designed as a randomized, two-group, Phase III trial conducted in subjects with the highest level of trauma activation and predicted to have a massive transfusion. Subjects at 12 North American level 1 trauma centres were randomized into one of two standard transfusion ratio interventions: 1:1:1 or 1:1:2, (plasma, platelets, and red blood cells). Clinical data and serial blood samples were collected under Exception from Informed Consent (EFIC) regulations. Co-primary mortality endpoints of 24 h and 30 days were evaluated. Results Between August 2012 and December 2013, 680 patients were randomized. The overall median time from admission to randomization was 26 min. PROPPR enrolled at higher than expected rates with fewer than expected protocol deviations. Conclusion PROPPR is the largest randomized study to enrol severely bleeding patients. This study showed that rapidly enrolling and successfully providing randomized blood products to severely injured patients in an EFIC study is feasible. PROPPR was able to achieve these goals by utilizing a collaborative structure and developing successful procedures and design elements that can be part of future trauma studies.

    KW - Clinical trial

    KW - Plasma

    KW - Platelets

    KW - Resuscitation

    KW - Transfusion

    KW - Trauma

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