Control of Major Bleeding After Trauma Study

• Status: Terminated
• Trial end date: 2017-04-03
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Denver Health and Hospital Authority
• Collaborators: U.S. Army Medical Research and Development Command; U.S. Army Medical Research and Materiel Command; University of Colorado, Denver

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.