Control of Major Bleeding After Trauma Study (COMBAT)

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ClinicalTrials.gov Identifier: NCT01838863

Recruitment Status : Terminated (Futility.)

First Posted : April 24, 2013

Last Update Posted : February 23, 2018

Sponsor:

Collaborators:

U.S. Army Medical Research and Materiel Command

University of Colorado, Denver

Information provided by (Responsible Party):

Ernest E. Moore, MD, Denver Health and Hospital Authority

Study Description

Brief Summary:

Bleeding is the most avoidable cause of death in trauma patients. Up to one-third of severely injured trauma patients are found to be coagulopathic and forty percent of the mortality following severe injury is due to uncontrollable hemorrhage in the setting of coagulopathy. It has been established that early administration of fresh frozen plasma decreases mortality following severe injury, replacing lost coagulation factors, improving the coagulopathy and restoring blood volume. This study will determine if giving plasma to severely injured trauma patients during ambulance transport versus after arrival to the hospital will help reduce hemorrhage, thus decreasing both total blood product administration and mortality.

Condition or disease	Intervention/treatment	Phase
Trauma Hemorrhagic Shock	Biological: Type AB plasma Drug: Crystalloid fluid (standard of care for resuscitation)	Phase 2

Detailed Description:

Study Design: Severely injured trauma patients with a systolic blood pressure (SBP) ≤ 70 or SBP ≤ 90 with a heart rate ≥ 108 bpm at the scene will be enrolled and randomized to receive either 2 units of frozen plasma thawed in the field or normal saline (the current standard of care), as the initial resuscitation fluid. After this initial resuscitation fluid, both groups will receive the same standard of care, including packed red blood cells, additional normal saline, or plasma as needed based on laboratory and clinical evidence of coagulopathy. Blood samples and clinical information will be collected throughout the hospital stay up to 28 days after injury.

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	144 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Prospective, Randomized Comparison of Fresh Frozen Plasma Versus Standard Crystalloid Intravenous Fluid as Initial Resuscitation Fluid
Actual Study Start Date :	April 7, 2014
Actual Primary Completion Date :	April 3, 2017
Actual Study Completion Date :	April 3, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Wounds and Injuries

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Plasma If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.	Biological: Type AB plasma The plasma is thawed and administered to subjects in the experimental (plasma) arm. Other Name: frozen plasma in 24 hours (FP24, PF24)
Active Comparator: Standard If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.	Drug: Crystalloid fluid (standard of care for resuscitation) Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid Other Name: normal saline

Arm

Intervention/treatment

Experimental: Plasma

If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.

Biological: Type AB plasma

The plasma is thawed and administered to subjects in the experimental (plasma) arm.

Other Name: frozen plasma in 24 hours (FP24, PF24)

Active Comparator: Standard

If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Drug: Crystalloid fluid (standard of care for resuscitation)

Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

Other Name: normal saline

Outcome Measures

Primary Outcome Measures :

28 day mortality [ Time Frame: 28 days ]
death within 28 days post injury (death of any cause except for death due to a second, clearly unrelated traumatic injury suffered after discharge)

Secondary Outcome Measures :

Composite outcome of 28-day in-hospital mortality and postinjury multiple organ failure (MOF) incidence [ Time Frame: 28 days ]
The occurrence of in-hospital death or MOF within the first 28 days postinjury. MOF is defined using the validated Denver MOF score (Denver MOF score>3 of simultaneously obtained scores after 48 hours postinjury).
Admission coagulopathy [ Time Frame: within 30 minutes of Emergency Department (ED) arrival ]
defined as the first international normalized ratio (INR) obtained upon ED arrival
Admission clot strength [ Time Frame: within 30 minutes of ED arrival ]
Admission clot strength will be measured by thrombelastography G-value upon ED arrival.
Admission acidosis [ Time Frame: Within 30 minutesof ED arrival ]
Admission acidosis will be defined through base deficit (BD) or lactate levels upon ED arrival.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age>=18 years
Acutely injured
SBP<70 mmHg or SBP 71-90 mmHg with heart rate (HR)>108 beats per minute.

Exclusion Criteria:

Visibly or verbally reported pregnant women
known prisoners
unsalvageable injuries (defined as asystolic or cardiopulmonary resuscitation prior to randomization)
known objection to blood products
the patient has an opt-out bracelet or, necklace or wallet card
a family member present at the scene objects to the patient's enrollment in research.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01838863

Locations


United States, Colorado
Denver Health Medical Center
Denver, Colorado, United States, 80204

Sponsors and Collaborators

Denver Health and Hospital Authority

U.S. Army Medical Research and Materiel Command

University of Colorado, Denver

Investigators


Principal Investigator:	Ernest E Moore, MD	Denver Health Medical Center

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Reynolds PS, Michael MJ, Cochran ED, Wegelin JA, Spiess BD. Prehospital use of plasma in traumatic hemorrhage (The PUPTH Trial): study protocol for a randomised controlled trial. Trials. 2015 Jul 30;16:321. doi: 10.1186/s13063-015-0844-5.

Chapman MP, Moore EE, Chin TL, Ghasabyan A, Chandler J, Stringham J, Gonzalez E, Moore HB, Banerjee A, Silliman CC, Sauaia A. Combat: Initial Experience with a Randomized Clinical Trial of Plasma-Based Resuscitation in the Field for Traumatic Hemorrhagic Shock. Shock. 2015 Aug;44 Suppl 1:63-70. doi: 10.1097/SHK.0000000000000376.


Responsible Party:	Ernest E. Moore, MD, Professor and Vice Chair, Department of Surgery, Denver Health and Hospital Authority
ClinicalTrials.gov Identifier:	NCT01838863 History of Changes
Other Study ID Numbers:	COMIRB# 12-1349 W81XWH1220028 ( Other Grant/Funding Number: Department of Defense TATRC )
First Posted:	April 24, 2013 Key Record Dates
Last Update Posted:	February 23, 2018
Last Verified:	February 2018

Keywords provided by Ernest E. Moore, MD, Denver Health and Hospital Authority:


coagulopathy hemorrhagic shock plasma blood product transfusion

Additional relevant MeSH terms:


Shock, Hemorrhagic Hemorrhage Pathologic Processes Shock

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