Recruiting
Phase 3

Plasma Resuscitation

Sponsor:

Jason Sperry

Code:

NCT07212998

Conditions

Burn Injury

Thermal Burn

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Plasma

Standard care

Study Details

Brief summary:

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.

Conditions

Burn Injury

Thermal Burn

Study ID

NCT07212998

Start date

Aug 31, 2026

Status verified date

Aug, 2026

Completion date

Sep, 2029

Anticipated

Primary completion date

Aug, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

750 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Early Plasma Resuscitation

Subjects will receive early plasma resuscitation initiated in the emergency department/burn resuscitation area over an approximate 4-hour period from the time of randomization, stratified by Total Body Surface Area (TBSA)%.

active comparator: Standard Care

Subjects will receive resuscitation following individual site standard burn resuscitation practice.

Interventions

Plasma

urgent release early plasma resuscitation following burn/thermal injury

Standard care

Standard resuscitation as dictated by institutional protocol

Primary outcome measure

  • 28-day Mortality or Persistent Organ Dysfunction [ Time Frame: 28 days ]

Central Contacts and Locations

Central contacts

Jason Sperry, MD

4128028270sperryjl@upmc.edu

Locations

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Jason Sperry, MD

412-647-3065sperryjl@upmc.edu

More Information

Sponsor

Jason Sperry

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Keywords

  • burn
  • plasma resuscitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jason Sperry on 2026-09-01.