Control of Major Bleeding After Trauma Study (COMBAT)
Trauma, Hemorrhagic Shock
About this trial
This is an interventional treatment trial for Trauma focused on measuring coagulopathy, hemorrhagic shock, plasma, blood product transfusion
Eligibility 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.
Sites / Locations
- Denver Health Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Plasma
Standard
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 emergency department (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 the hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.
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 packed red blood cells pRBC administration determined by the hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.