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 A. Schreiber, Kenji Inaba, Timothy C. Fabian, Jeffrey D. Kerby, Mitchell Jay Cohen, Christopher N. Miller, Sandro Rizoli, Thomas M. Scalea, Terence OKeeffe, Karen J. BraselBryan A. Cotton, Peter Muskat, John B. Holcomb

Research output: Contribution to journalArticle

69 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 - Jan 1 2014

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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

  • Emergency Medicine
  • Orthopedics and Sports 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 A.; Inaba, Kenji; Fabian, Timothy C.; Kerby, Jeffrey D.; Cohen, Mitchell Jay; Miller, Christopher N.; Rizoli, Sandro; Scalea, Thomas M.; OKeeffe, Terence; Brasel, Karen J.; Cotton, Bryan A.; Muskat, Peter; Holcomb, John B.

In: Injury, Vol. 45, No. 9, 01.01.2014, 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, MA, Inaba, K, Fabian, TC, Kerby, JD, Cohen, MJ, Miller, CN, Rizoli, S, Scalea, TM, OKeeffe, T, Brasel, KJ, 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 A. ; Inaba, Kenji ; Fabian, Timothy C. ; Kerby, Jeffrey D. ; Cohen, Mitchell Jay ; Miller, Christopher N. ; Rizoli, Sandro ; Scalea, Thomas M. ; OKeeffe, Terence ; Brasel, Karen J. ; 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.",
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AU - Baraniuk, Sarah

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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 A.

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 - OKeeffe, Terence

AU - Brasel, Karen J.

AU - Cotton, Bryan A.

AU - Muskat, Peter

AU - Holcomb, John B.

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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.

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KW - Platelets

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