Status:
WITHDRAWN
Pre-Hospital Use of Plasma for Traumatic Hemorrhage
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
United States Department of Defense
Conditions:
Shock, Hemorrhagic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Type A Thawed Plasma (TP) will be compared in polytrauma patients who receive only Normal Saline (NS) (standard of care) before arrival at the hospital. The purpose of this study is to determine if p...
Detailed Description
INVESTIGATIONAL PLAN This will be an open-label, non-blinded, randomized clinical trial to investigate mortality (30 days) and morbidity of Type A thawed Plasma (TP) versus NS infusion at earliest con...
Eligibility Criteria
Inclusion
- Blunt or penetrating trauma,
- Blood Pressure (BP) systolic \<70 mmHg or BP 70-90 mmHg with Heart Rate (HR) \> 108 Beats Per Minute (BPM),
- Ongoing hemorrhage with unstable vital signs
Exclusion
- Wearing opt-out wrist band,
- Wearing medical alert jewelry / bracelet, etc. indicating Jehovah Witness or similar with objections to blood transfusions,
- Refusal to participate (by subject or LAR),
- Communication barrier at the time of eliciting refusal (non-English speaking or non-Spanish speaking),
- Not expected to survive transport to Virginia Commonwealth University Medical Center (VCUMC),
- Documented Do Not Resuscitate (DNR) order found,
- Cardiac arrest or Cardio-Pulmonary Resuscitation (CPR) prior to randomization
- Penetrating head trauma,
- Known / obvious pregnancy,
- Prisoner,
- Burns \> 20% of body surface
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02303964
Start Date
November 1 2014
End Date
January 1 2016
Last Update
February 23 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298