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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Jason Sperry
Study ID
NCT07212998
Phase
PHASE3
Status
Recruiting
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Conditions

  • Burn Injury
  • Thermal Burn

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Plasma — BIOLOGICAL
    urgent release early plasma resuscitation following burn/thermal injury
  • Standard care — BIOLOGICAL
    Standard resuscitation as dictated by institutional protocol

Study Details

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.

Key Dates

First listed
Oct 8, 2025
Start date
Aug 31, 2026
Status verified
Aug 2026
Primary completion
Aug 31, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
750 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of PittsburghPittsburghPennsylvania15213
Jason Sperry, MD
[email protected]
412-647-3065

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By research site
University of Pittsburgh· Pittsburgh, PA

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