Control of Major Bleeding After Trauma Study

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-07

Study Completion Date

2017-04-03

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Trauma Hemorrhagic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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 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.

Group Type EXPERIMENTAL

Type AB plasma

Intervention Type BIOLOGICAL

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

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 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.

Group Type ACTIVE_COMPARATOR

Crystalloid fluid (standard of care for resuscitation)

Intervention Type DRUG

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

Interventions

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Type AB plasma

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

Intervention Type BIOLOGICAL

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

Intervention Type DRUG

Other Intervention Names

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Plasma frozen within 24 hours (FP24, PF24) Normal saline

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No