Sarah Baraniuk1, Barbara C Tilley2, Deborah J del Junco3, Erin E Fox3, Gerald van Belle4, Charles E Wade3, Jeanette M Podbielski3, Angela M Beeler3, John R Hess5, Eileen M Bulger6, Martin A Schreiber7, Kenji Inaba8, Timothy C Fabian9, Jeffrey D Kerby10, Mitchell Jay Cohen11, Christopher N Miller12, Sandro Rizoli13, Thomas M Scalea14, Terence O'Keeffe15, Karen J Brasel16, Bryan A Cotton3, Peter Muskat17, John B Holcomb3. 1. Division of Biostatistics, School of Public Health, University of Texas Health Science Center at Houston, United States. Electronic address: Mary.Baraniuk@uth.tmc.edu. 2. Division of Biostatistics, School of Public Health, University of Texas Health Science Center at Houston, United States. 3. Center for Translational Injury Research, Division of Acute Care Surgery, Department of Surgery, Medical School, University of Texas Health Science Center at Houston, United States. 4. Department of Environmental and Occupational Health Sciences and Department of Biostatistics, School of Public Health, University of Washington, United States. 5. Department of Laboratory Medicine, School of Medicine, University of Washington, United States. 6. Division of Trauma and Critical Care, Department of Surgery, School of Medicine, University of Washington, United States. 7. Division of Trauma, Critical Care and Acute Care Surgery, School of Medicine, Oregon Health & Science University, United States. 8. Division of Trauma and Critical Care, University of Southern California, United States. 9. Division of Trauma and Surgical Critical Care, Department of Surgery, Medical School, University of Tennessee Health Science Center, United States. 10. Division of Trauma, Burns and Surgical Critical Care, Department of Surgery, School of Medicine, University of Alabama at Birmingham, United States. 11. Division of General Surgery, Department of Surgery, School of Medicine, University of California, San Francisco, United States. 12. Department of Emergency Medicine, College of Medicine, University of Cincinnati, United States. 13. Trauma and Acute Care Surgery, St Michael's Hospital, University of Toronto, Canada. 14. R Adams Cowley Shock Trauma Center, Program in Trauma, University of Maryland School of Medicine, United States. 15. Division of Trauma, Critical Care and Emergency Surgery, Department of Surgery, University of Arizona, United States. 16. Division of Trauma and Critical Care, Department of Surgery, Medical College of Wisconsin, United States. 17. Division of Trauma/Critical Care, Department of Surgery, College of Medicine, University of Cincinnati, United States.
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 24h 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 26min. 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.
RCT Entities:
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 24h 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 26min. PROPPR enrolled at higher than expected rates with fewer than expected protocol deviations. CONCLUSION: PROPPR is the largest randomized study to enrol severely bleedingpatients. 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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