Status:
COMPLETED
Type O Whole Blood and Assessment of Age During Prehospital Resuscitation Trial
Lead Sponsor:
Jason Sperry
Collaborating Sponsors:
United States Department of Defense
Conditions:
Hemorrhagic Shock
Traumatic Injury
Eligibility:
All Genders
18-89 years
Phase:
PHASE3
Brief Summary
Open label, multi-center, pre-hospital randomized trial utilizing 10 level-1 trauma centers designed to determine the efficacy and safety of low titer whole blood resuscitation as compared to standard...
Eligibility Criteria
Inclusion
- ) Injured patients at risk of hemorrhagic shock being transported from scene or referral hospital to a participating TOWAR trial site that meet requirements for initiation of blood or blood component transfusion
- AND
- 2A.) Systolic blood pressure ≤ 90mmHg and tachycardia (HR ≥ 108) at scene, at outside hospital or during transport OR
- 2B.) Systolic blood pressure ≤ 70mmHg at scene, at outside hospital or during transport
Exclusion
- Wearing NO TOWAR opt-out bracelet
- Age \> 90 or \< 18 years of age
- Isolated fall from standing injury mechanism
- Known prisoner or known pregnancy
- Traumatic arrest with \> 5 minutes of CPR without return of vital signs
- Brain matter exposed or penetrating brain injury (GSW)
- Isolated drowning or hanging victims
- Objection to study voiced by subject or family member at the scene
- Inability to obtain IV or intraosseous access
- Isolated burns without evidence of traumatic injury
Key Trial Info
Start Date :
April 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 12 2025
Estimated Enrollment :
1020 Patients enrolled
Trial Details
Trial ID
NCT04684719
Start Date
April 19 2022
End Date
August 12 2025
Last Update
August 22 2025
Active Locations (10)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
University of Louisville
Louisville, Kentucky, United States, 40292
3
University of Mississippi Medical Center (UMMC)
Jackson, Mississippi, United States, 39216
4
University of Cincinatti
Cincinnati, Ohio, United States, 45267