Status:
TERMINATED
Control of Major Bleeding After Trauma Study
Lead Sponsor:
Denver Health and Hospital Authority
Collaborating Sponsors:
U.S. Army Medical Research and Development Command
University of Colorado, Denver
Conditions:
Trauma
Hemorrhagic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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 ...
Eligibility Criteria
Inclusion
- Age\>=18 years
- Acutely injured
- SBP\<70 mmHg or SBP 71-90 mmHg with heart rate (HR)\>108 beats per minute.
Exclusion
- 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.
Key Trial Info
Start Date :
April 7 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 3 2017
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT01838863
Start Date
April 7 2014
End Date
April 3 2017
Last Update
January 8 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Denver Health Medical Center
Denver, Colorado, United States, 80204