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Goal-directed Hemostatic Resuscitation of Trauma-induced Coagulopathy: A Pragmatic Randomized Clinical Trial Comparing a Viscoelastic Assay to Conventional Coagulation Assays

Gonzalez, Eduardo MD; Moore, Ernest E. MD; Moore, Hunter B. MD; Chapman, Michael P. MD; Chin, Theresa L. MD; Ghasabyan, Arsen MPH; Wohlauer, Max V. MD; Barnett, Carlton C. MD; Bensard, Denis D. MD; Biffl, Walter L. MD; Burlew, Clay C. MD; Johnson, Jeffrey L. MD; Pieracci, Fredric M. MD, MPH; Jurkovich, Gregory J. MD; Banerjee, Anirban PhD; Silliman, Christopher C. MD, PhD; Sauaia, Angela MD, PhD

doi: 10.1097/SLA.0000000000001608
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Background: Massive transfusion protocols (MTPs) have become standard of care in the management of bleeding injured patients, yet strategies to guide them vary widely. We conducted a pragmatic, randomized clinical trial (RCT) to test the hypothesis that an MTP goal directed by the viscoelastic assay thrombelastography (TEG) improves survival compared with an MTP guided by conventional coagulation assays (CCA).

Methods: This RCT enrolled injured patients from an academic level-1 trauma center meeting criteria for MTP activation. Upon MTP activation, patients were randomized to be managed either by an MTP goal directed by TEG or by CCA (ie, international normalized ratio, fibrinogen, platelet count). Primary outcome was 28-day survival.

Results: One hundred eleven patients were included in an intent-to-treat analysis (TEG = 56, CCA = 55). Survival in the TEG group was significantly higher than the CCA group (log-rank P = 0.032, Wilcoxon P = 0.027); 20 deaths in the CCA group (36.4%) compared with 11 in the TEG group (19.6%) (P = 0.049). Most deaths occurred within the first 6 hours from arrival (21.8% CCA group vs 7.1% TEG group) (P = 0.032). CCA patients required similar number of red blood cell units as the TEG patients [CCA: 5.0 (2–11), TEG: 4.5 (2–8)] (P = 0.317), but more plasma units [CCA: 2.0 (0–4), TEG: 0.0 (0–3)] (P = 0.022), and more platelets units [CCA: 0.0 (0–1), TEG: 0.0 (0–0)] (P = 0.041) in the first 2 hours of resuscitation.

Conclusions: Utilization of a goal-directed, TEG-guided MTP to resuscitate severely injured patients improves survival compared with an MTP guided by CCA and utilizes less plasma and platelet transfusions during the early phase of resuscitation.

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*Department of Surgery, University of Colorado, Denver, CO

Department of Surgery, Denver Health Medical Center, Denver, CO

Department of Pediatrics, University of Colorado, Denver, CO

§Research Laboratory, Bonfils Blood Center, Denver, CO

Colorado School of Public Health, University of Colorado, Denver, CO.

Reprints: Ernest E. Moore, MD, Journal of Trauma and Acute Care Surgery, 655 Broadway, Suite 365, Denver, CO 80203. E-mail: ernest.moore@dhha.org.

The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIGMS or National Institutes of Health.

Funding: Support was provided in the way of laboratory reagents by Haemonetics Inc, which had no role in the study design, data collection, data analysis, data interpretation of the study, or preparation of this manuscript. The investigators requested this support after the study was initially conceived. Haemonetics Inc provided no salary or financial compensation to any of the authors or managing physicians. Funding by National Institute of General Medical Sciences and National Heart, Lung, and Blood Institute.

Disclosures: The authors EG, EEM, HBM, and MPC received support from Haemonetics Inc in the way of laboratory reagents.

The author reports no conflicts of interest.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Website (www.annalsofsurgery.com).

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