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
|Condition or disease||Intervention/treatment||Phase|
|Trauma Hemorrhagic Shock||Biological: Type AB plasma Drug: Crystalloid fluid (standard of care for resuscitation)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||144 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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)
- 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.
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
|United States, Colorado|
|Denver Health Medical Center|
|Denver, Colorado, United States, 80204|
|Principal Investigator:||Ernest E Moore, MD||Denver Health Medical Center|