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Control of Major Bleeding After Trauma Study

NCT01838863 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2019-01-08

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

Type AB plasma

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

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

Sponsors & Collaborators

  • U.S. Army Medical Research and Development Command

    collaborator FED

  • University of Colorado, Denver

    collaborator OTHER

  • Denver Health and Hospital Authority

    lead OTHER

Principal Investigators

  • Ernest E Moore, MD · Denver Health Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-07
Primary Completion
2017-04-03
Completion
2017-04-03

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01838863 on ClinicalTrials.gov