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Not yet recruiting NCT07212998

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

Phase III Interventional Burn Injury Thermal Burn

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Plasma, Standard care.
Who it may be relevant to
Registry conditions: Burn Injury, Thermal Burn. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

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

Primary outcome measures

  • 28-day Mortality or Persistent Organ Dysfunction [Time frame: 28 days]
Secondary outcome measures (12)
  • 14-day mortality or Persistent Organ Dysfunction [Time frame: 14 days]
  • Arterial or venous thromboembolism in first 7 days [Time frame: 7 days]
  • Acute respiratory distress syndrome (ARDS) in first 7 days [Time frame: 7 days]
  • Abdominal compartment syndrome [Time frame: Enrollment through hospital discharge or 28 days]
  • In-hospital mortality [Time frame: Enrollment through hospital discharge or 28 days]
  • 24-hour and 48-hour resuscitation [Time frame: Enrollment through 24 hours and 48 hours]
  • Acute kidney injury [Time frame: Between 24 and 72 hours from the time of randomization]
  • Nosocomial Infection [Time frame: 28 days]
  • Ventilator-free days [Time frame: 28 days]
  • ICU- free days [Time frame: 28 days]
  • Allergic/transfusion reaction [Time frame: Initial 12 hours from randomization]
  • Persistent Organ Dysfunction (POD) Days [Time frame: Starting at day of randomization and ending at day 28]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Pittsburgh — Pittsburgh

Identifiers

NCT: NCT07212998 · STUDY25030138 · HT9425-24-3-0002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗