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RECRUITING Phase 3 ClinicalTrials.gov

Plasma Resuscitation Early for Evaluating Volume and Endotheliopathy of Thermal Injury (PREEVEnT) Trial

Sponsor: Jason Sperry • ClinicalTrials.gov ID: NCT07212998

Registry updated: 2026-09-01
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Description

The Plasma Resuscitation Early for Evaluating Volume and Endotheliopathy of Thermal Injury (PREEVEnT) trial will be a 5-year (3-year enrollment), open label, phase-3, multi-center, early in-hospital phase randomized trial utilizing burn centers from within the LITES network and will enroll approximately 750 injured adult patients who have suffered large 2nd or 3rd degree thermal burns on at least 20% of their body surface requiring burn resuscitation. The objective is to determine if initiating plasma resuscitation as soon as possible upon arrival to an emergency department or burn unit is the most effective resuscitation for those who have experienced large thermal burns and significantly reduces the morbidity and mortality attributable to post-injury complications as compared to standard in-hospital resuscitation practice.

Interventions

  • Plasma (Biological)
    urgent release early plasma resuscitation following burn/thermal injury
  • Standard care (Biological)
    Standard resuscitation as dictated by institutional protocol

Eligibility criteria

Inclusion Criteria: * Estimated ≥ 20% Total Body Surface Area burn/thermal injury with 2nd or 3rd degree depth * Anticipated admission to burn ICU Exclusion Criteria: * 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

Conditions

Burn Injury Thermal Burn

Locations

  • University of Pittsburgh — Pittsburgh, Pennsylvania, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record