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Control of Major Bleeding After Trauma Study (COMBAT)

Primary Purpose

Trauma, Hemorrhagic Shock

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Type AB plasma

Crystalloid fluid (standard of care for resuscitation)

About this trial

This is an interventional treatment trial for Trauma focused on measuring coagulopathy, hemorrhagic shock, plasma, blood product transfusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Active Comparator

Arm Label

Plasma

Standard

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of Participants That Died Within 28 Days Post Injury

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

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

Defined as the first international normalized ratio (INR) obtained upon ED arrival. The international normalized ratio (INR) is an international standard for the prothrombin time (PT). This measures the time it takes for blood to clot. The normal range for a healthy person is 0.83-1.19. Usually, a high INR indicates a higher risk of bleeding, while a low INR suggests a higher risk of developing a clot.

Number of Participants With Admission Severe Coagulopathy

Defined as international normalized ratio (INR) >1.3 obtained upon ED arrival. The international normalized ratio (INR) is an international standard for the prothrombin time (PT). This measures the time it takes for blood to clot. The normal range for a healthy person is 0.83-1.19. Usually, a high INR indicates a higher risk of bleeding, while a low INR suggests a higher risk of developing a clot.

Admission Clot Strength

Admission clot strength will be measured by thrombelastography G-value upon ED arrival. Clot strength measured in kilodynes per square centimetre (kdyn/cm^2).

Admission Acidosis

Admission acidosis measured by lactate upon ED arrival.

Number of Participants With Admission Severe Acidosis

Admission severe acidosis measured by lactate>5 upon ED arrival.

Admission Acidosis

Admission acidosis will be defined by base deficit (BD) upon ED arrival.

Number of Participants With Admission Severe Acidosis

Admission severe acidosis will be defined by base deficit (BD>10) upon ED arrival.

Full Information

NCT ID

NCT01838863

First Posted

April 22, 2013

Last Updated

December 15, 2018

Sponsor

Denver Health and Hospital Authority

Collaborators

U.S. Army Medical Research and Development Command, University of Colorado, Denver

1. Study Identification

Unique Protocol Identification Number

NCT01838863

Brief Title

Control of Major Bleeding After Trauma Study

Acronym

COMBAT

Official Title

A Prospective, Randomized Comparison of Fresh Frozen Plasma Versus Standard Crystalloid Intravenous Fluid as Initial Resuscitation Fluid

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Terminated

Why Stopped

Futility

Study Start Date

April 7, 2014 (Actual)

Primary Completion Date

April 3, 2017 (Actual)

Study Completion Date

April 3, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Denver Health and Hospital Authority

Collaborators

U.S. Army Medical Research and Development Command, University of Colorado, Denver

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Trauma, Hemorrhagic Shock

Keywords

coagulopathy, hemorrhagic shock, plasma, blood product transfusion

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

144 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Plasma

Arm Type

Experimental

Arm Description

Arm Title

Standard

Arm Type

Active Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

Type AB plasma

Other Intervention Name(s)

Plasma frozen within 24 hours (FP24, PF24)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Crystalloid fluid (standard of care for resuscitation)

Other Intervention Name(s)

Normal saline

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of Participants That Died Within 28 Days Post Injury

Description

death within 28 days post injury (death of any cause except for death due to a second, clearly unrelated traumatic injury suffered after discharge)

Time Frame

28 days

Secondary Outcome Measure Information:

Title

Composite Outcome of 28-day In-hospital Mortality and Postinjury Multiple Organ Failure (MOF) Incidence

Description

Time Frame

28 days

Title

Admission Coagulopathy

Description

Time Frame

within 30 minutes of Emergency Department (ED) arrival

Title

Number of Participants With Admission Severe Coagulopathy

Description

Time Frame

within 30 minutes of Emergency Department (ED) arrival

Title

Admission Clot Strength

Description

Admission clot strength will be measured by thrombelastography G-value upon ED arrival. Clot strength measured in kilodynes per square centimetre (kdyn/cm^2).

Time Frame