Format

Send to

Choose Destination
See comment in PubMed Commons below
Injury. 2014 Sep;45(9):1287-95. doi: 10.1016/j.injury.2014.06.001. Epub 2014 Jun 10.

Pragmatic Randomized Optimal Platelet and Plasma Ratios (PROPPR) Trial: design, rationale and implementation.

Collaborators (146)

Holcomb JB, Wade CE, del Junco DJ, Fox EE, Matijevic N, Podbielski J, Beeler AM, Tilley BC, Baraniuk S, Nixon J, Yang H, Gonzalez MO, Appana SN, Seay R, Baer L, Appana SN, Seay R, Wang YW, Hula BS, Espino E, Nguyen A, Pawelczyk N, Arora-Nutall KD, Sharma R, Cardenas JC, Rahbar E, Burnett T Jr, Clark D, van Belle G, May S, Leroux B, Hoyt D, Powell J, Sheehan K, Hubbard A, Arkin AP, Hess JR, Callum J, Cotton BA, Vincent L, Welch T, Poole T, Pivalizza EG, Gumbert SD, Bai Y, McCarthy JJ, Noland A, Hobbs R, Bulger EM, Klotz P, Cattin L, Warner KJ, Wilson A, Boman D, White N, Grabinsky A, Daniel-Johnson JA, Cohen MJ, Callcut RA, Nelson M, Redick B, Conroy A, Steurer MP, Maxim PC, Fiebig E, Moore J, Mallari E, Muskat P, Johannigman JA, Robinson BR, Branson RD, Gomaa D, Barczak C, Bennett S, Carey PM, Miller CN, Hancock H, Rodriguez C, Inaba K, Zhu JG, Wong MD, Menchine M, Katzberg K, Henderson SO, McKeever R, Shulman IA, Nelson JM, Tuma CW, Matsushita CY, Scalea TM, Stein DM, Shaffer CK, Wade C, Herrera AV, Kallam S, Wade SE, Shaffer CK, Galvagno SM Jr, Fontaine MJ, Hunt JM, Cooke RK, Fabian TC, Weinberg J, Croce MA, Wilson S, Panzer-Baggett S, Waddle-Smith L, Flax S, Brasel KJ, Walsh P, Milia D, Nelson A, Kaslow O, Aufderheide TP, Gottschall JL, Carpenter E, O'Keeffe T, Rokowski LL, Denninghoff KR, Redford DT, Novak DJ, Knoll S, Kerby JD, Pittet JF, Bosarge PL, Williams CR, Stephens SW, Wang HE, Marques MB, Schreiber MA, Watters JM, Underwood SJ, Groat T, Newgard C, Merkel M, Scanlan RM, Miller B, Rizoli S, Tien H, Nascimento B, Trpcic S, Sobrian-Couroux S, Reis M, Pérez A, Belo SE, Colavecchia C.

Author information

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01545232.

KEYWORDS:

Clinical trial; Plasma; Platelets; Resuscitation; Transfusion; Trauma

PMID:
24996573
PMCID:
PMC4137482
DOI:
10.1016/j.injury.2014.06.001
[Indexed for MEDLINE]
Free PMC Article
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for Elsevier Science Icon for PubMed Central
    Loading ...
    Support Center