Combat: Initial Experience with a Randomized Clinical Trial of Plasma-Based Resuscitation in the Field for Traumatic Hemorrhagic Shock

Shock
Michael C ChapmanAngela Sauaia

Abstract

The existing evidence shows great promise for plasma as the first resuscitation fluid in both civilian and military trauma. We embarked on the Control of Major Bleeding After Trauma (COMBAT) trial with the support of the Department of Defense to determine if plasma-first resuscitation yields hemostatic and survival benefits. The methodology of the COMBAT study represents not only 3 years of development work but also the integration of nearly two decades of technical experience with the design and implementation of other clinical trials and studies. Herein, we describe the key features of the study design, critical personnel and infrastructural elements, and key innovations. We will also briefly outline the systems engineering challenges entailed by this study. The COMBAT trial is a randomized, placebo-controlled, semiblinded, prospective, phase IIB clinical trial conducted in a ground ambulance fleet based at a level I trauma center and part of a multicenter collaboration. The primary objective of the COMBAT trial is to determine the efficacy of field resuscitation with plasma first compared with standard of care (normal saline). To date, we have enrolled 30 subjects in the COMBAT study. The ability to achieve intervention with...Continue Reading

Associated Clinical Trials

Apr 24, 2013·Ernest E. Moore, MD, Ernest E. Moore, MD

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Citations

Jul 16, 2015·Shock·Michael A Dubick, Anthony E Pusateri
Jan 31, 2016·Shock·Iain M SmithMark J Midwinter
Oct 19, 2016·Shock·Justin J J WatsonMartin A Schreiber
Jan 26, 2018·The Journal of Trauma and Acute Care Surgery·David W Callaway
Sep 21, 2018·Anesthesia and Analgesia·Sergio B NavarreteMichael J Scott
Dec 1, 2017·European Journal of Emergency Medicine : Official Journal of the European Society for Emergency Medicine·Joost H PetersMichael J R Edwards
Oct 26, 2018·The Journal of Trauma and Acute Care Surgery·Ernest E Moore
Jun 2, 2020·Transfusion·Bryon JacksonMagali J Fontaine
May 26, 2017·The Journal of Trauma and Acute Care Surgery·Matthew C HernandezScott P Zietlow
Oct 22, 2016·The Journal of Trauma and Acute Care Surgery·Zhanglong PengRosemary A Kozar
Sep 8, 2020·Vox Sanguinis·Gregory R StettlerChristopher C Silliman
Jun 10, 2017·Current Problems in Surgery·Matthew BradleyNorman M Rich
Aug 17, 2021·Frontiers in Veterinary Science·Kelly Hall, Kenneth Drobatz

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