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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Page 1 of 1 (1 locations)

1

University of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15213