Status:
NOT_YET_RECRUITING
Plasma Resuscitation Early for Evaluating Volume and Endotheliopathy of Thermal Injury (PREEVEnT) Trial
Lead Sponsor:
Jason Sperry
Collaborating Sponsors:
United States Department of Defense
Conditions:
Burn Injury
Thermal Burn
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The Plasma Resuscitation Early for Evaluating Volume and Endotheliopathy of Thermal Injury (PREEVEnT) trial will be a 6-year (4-year enrollment), open label, phase-3, multi-center, early in-hospital p...
Eligibility Criteria
Inclusion
- Estimated ≥ 20% Total Body Surface Area burn/thermal injury with 2nd or 3rd degree depth
- Anticipated admission to burn ICU
Exclusion
- Estimated rBaux score \<55
- Not expected to survive \>24 hours
- Wearing NO PREEVENT opt-out bracelet
- Age \> 75 or \< 18 years of age
- Concomitant traumatic injury with hemorrhagic shock
- Isolated chemical burn/injury
- Isolated deep electrical burn/injury
- Known prisoner
- Known pregnancy
- Cardiac arrest with \> 5 continuous minutes of CPR
- Concern for anoxic injury/ fixed pupils bilaterally
- Objection to study voiced by subject or family member at the scene or at the emergency department/burn center
Key Trial Info
Start Date :
April 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2030
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT07212998
Start Date
April 1 2026
End Date
May 1 2030
Last Update
October 8 2025
Active Locations (1)
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1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213