Control of Major Bleeding After Trauma Study (COMBAT)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Denver Health and Hospital Authority
Sponsor:
Collaborators:
U.S. Army Medical Research and Materiel Command
University of Colorado, Denver
Information provided by (Responsible Party):
Ernest Moore, Denver Health and Hospital Authority
ClinicalTrials.gov Identifier:
NCT01838863
First received: April 22, 2013
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Comparison of Fresh Frozen Plasma Versus Standard Crystalloid Intravenous Fluid as Initial Resuscitation Fluid

Resource links provided by NLM:


Further study details as provided by Denver Health and Hospital Authority:

Primary Outcome Measures:
  • 28 day mortality [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    defined as the first international normalized ratio (INR) obtained upon ED arrival

  • Admission clot strength [ Time Frame: within 30 minutes of ED arrival ] [ Designated as safety issue: No ]
    Admission clot strength will be measured by thrombelastography G-value upon ED arrival.

  • Admission acidosis [ Time Frame: Within 30 minutesof ED arrival ] [ Designated as safety issue: No ]
    Admission acidosis will be defined through base deficit (BD) or lactate levels upon ED arrival.


Estimated Enrollment: 150
Study Start Date: April 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01838863

Locations
United States, Colorado
Denver Health Medical Center Not yet recruiting
Denver, Colorado, United States, 80204
Contact: Ernest E Moore, MD    303-602-1820    ernest.moore@dhha.org   
Principal Investigator: Ernest E Moore, MD         
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

No publications provided

Responsible Party: Ernest Moore, 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
Study First Received: April 22, 2013
Last Updated: March 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Denver Health and Hospital Authority:
coagulopathy
hemorrhagic shock
plasma
blood product transfusion

Additional relevant MeSH terms:
Shock, Hemorrhagic
Hemorrhage
Pathologic Processes
Shock

ClinicalTrials.gov processed this record on October 28, 2014