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JAMA. 2015 Feb 3;313(5):471-82. doi: 10.1001/jama.2015.12.

Transfusion of plasma, platelets, and red blood cells in a 1:1:1 vs a 1:1:2 ratio and mortality in patients with severe trauma: the PROPPR randomized clinical trial.

Collaborators (147)

Holcomb JB, Wade CE, del Junco DJ, Fox EE, Matijevic N, Podbielski JM, Beeler AM, Tilley BC, Baraniuk S, DeSantis SM, Zhu H, Nixon J, Seay R, Appana SN, Yang H, Gonzalez MO, Baer L, 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 JL, Pittet JF, Miller CN, 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, 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, Galvagno SM Jr, Fontaine MJ, Hunt JM, Cooke RK, Fabian TC, Weinberg JA, 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, Bosarge PL, Pierce AT, 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, Merkley L, Colavecchia C.

Author information

1
Center for Translational Injury Research, Division of Acute Care Surgery, Department of Surgery, Medical School, University of Texas Health Science Center, Houston.
2
Division of Biostatistics, School of Public Health, University of Texas Health Science Center, Houston.
3
Division of Trauma and Critical Care, Department of Surgery, Medical College of Wisconsin, Milwaukee22Dr Brasel is now with the Division of Trauma, Critical Care and Acute Care Surgery, School of Medicine, Oregon Health & Science University, Portland.
4
Division of Trauma and Critical Care, Department of Surgery, School of Medicine, University of Washington, Seattle.
5
Division of General Surgery, Department of Surgery, School of Medicine, University of California, San Francisco.
6
Division of Trauma and Surgical Critical Care, Department of Surgery, College of Medicine, University of Tennessee Health Science Center, Memphis.
7
Division of Trauma and Critical Care, University of Southern California, Los Angeles.
8
Division of Trauma, Burns and Surgical Critical Care, Department of Surgery, School of Medicine, University of Alabama, Birmingham.
9
Division of Trauma/Critical Care, Department of Surgery, College of Medicine, University of Cincinnati, Cincinnati, Ohio23Dr Muskat is now with the Division of General Surgery, Department of Surgery, School of Medicine, University of California, San Franc.
10
Division of Trauma, Critical Care and Emergency Surgery, Department of Surgery, University of Arizona, Tucson.
11
Trauma and Acute Care Surgery, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.
12
Division of Trauma/Critical Care, Department of Surgery, College of Medicine, University of Cincinnati, Cincinnati, Ohio.
13
R. Adams Cowley Shock Trauma Center, Program in Trauma, University of Maryland School of Medicine, Baltimore.
14
Division of Trauma, Critical Care and Acute Care Surgery, School of Medicine, Oregon Health & Science University, Portland.
15
Sunnybrook Research Institute, Department of Clinical Pathology, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.
16
Department of Laboratory Medicine, School of Medicine, University of Washington, Seattle.
17
Department of Emergency Medicine, College of Medicine, University of Cincinnati, Cincinnati, Ohio.
18
Division of Critical Care and Perioperative Medicine, Department of Anesthesiology, School of Medicine, University of Alabama, Birmingham.
19
American College of Surgeons, Chicago, Illinois.
20
Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.
21
Department of Biostatistics, School of Public Health, University of Washington, Seattle.
22
Department of Biostatistics, School of Public Health, University of Washington, Seattle21Department of Environmental and Occupational Health Sciences, School of Public Health, University of Washington, Seattle.

Abstract

IMPORTANCE:

Severely injured patients experiencing hemorrhagic shock often require massive transfusion. Earlier transfusion with higher blood product ratios (plasma, platelets, and red blood cells), defined as damage control resuscitation, has been associated with improved outcomes; however, there have been no large multicenter clinical trials.

OBJECTIVE:

To determine the effectiveness and safety of transfusing patients with severe trauma and major bleeding using plasma, platelets, and red blood cells in a 1:1:1 ratio compared with a 1:1:2 ratio.

DESIGN, SETTING, AND PARTICIPANTS:

Pragmatic, phase 3, multisite, randomized clinical trial of 680 severely injured patients who arrived at 1 of 12 level I trauma centers in North America directly from the scene and were predicted to require massive transfusion between August 2012 and December 2013.

INTERVENTIONS:

Blood product ratios of 1:1:1 (338 patients) vs 1:1:2 (342 patients) during active resuscitation in addition to all local standard-of-care interventions (uncontrolled).

MAIN OUTCOMES AND MEASURES:

Primary outcomes were 24-hour and 30-day all-cause mortality. Prespecified ancillary outcomes included time to hemostasis, blood product volumes transfused, complications, incidence of surgical procedures, and functional status.

RESULTS:

No significant differences were detected in mortality at 24 hours (12.7% in 1:1:1 group vs 17.0% in 1:1:2 group; difference, -4.2% [95% CI, -9.6% to 1.1%]; P = .12) or at 30 days (22.4% vs 26.1%, respectively; difference, -3.7% [95% CI, -10.2% to 2.7%]; P = .26). Exsanguination, which was the predominant cause of death within the first 24 hours, was significantly decreased in the 1:1:1 group (9.2% vs 14.6% in 1:1:2 group; difference, -5.4% [95% CI, -10.4% to -0.5%]; P = .03). More patients in the 1:1:1 group achieved hemostasis than in the 1:1:2 group (86% vs 78%, respectively; P = .006). Despite the 1:1:1 group receiving more plasma (median of 7 U vs 5 U, P < .001) and platelets (12 U vs 6 U, P < .001) and similar amounts of red blood cells (9 U) over the first 24 hours, no differences between the 2 groups were found for the 23 prespecified complications, including acute respiratory distress syndrome, multiple organ failure, venous thromboembolism, sepsis, and transfusion-related complications.

CONCLUSIONS AND RELEVANCE:

Among patients with severe trauma and major bleeding, early administration of plasma, platelets, and red blood cells in a 1:1:1 ratio compared with a 1:1:2 ratio did not result in significant differences in mortality at 24 hours or at 30 days. However, more patients in the 1:1:1 group achieved hemostasis and fewer experienced death due to exsanguination by 24 hours. Even though there was an increased use of plasma and platelets transfused in the 1:1:1 group, no other safety differences were identified between the 2 groups.

TRIAL REGISTRATION:

clinicaltrials.gov Identifier: NCT01545232.

PMID:
25647203
PMCID:
PMC4374744
DOI:
10.1001/jama.2015.12
[Indexed for MEDLINE]
Free PMC Article

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