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

NCT07212998 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: STUDY25030138HT9425-24-3-0002
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 1

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 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 resusciation. 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

Keywords

burn; plasma resuscitation

Outcome Measures

Primary Outcomes (1)

• 28-day Mortality or Persistent Organ Dysfunction

  Composite outcome consisting of 28-day all-cause mortality, or 28-day Persistent Organ Dysfunction (POD) requiring support defined as 1) any intravenous vasopressor requirement, or 2) any renal replace therapy, or 3) any ventilator support/mechanical ventilation, or 4) continued need for intensive care unit (ICU) admission at 28 days.

  28 days

Secondary Outcomes (12)

• 14-day mortality or Persistent Organ Dysfunction

  14 days

• Arterial or venous thromboembolism in first 7 days

  7 days

• Acute respiratory distress syndrome (ARDS) in first 7 days

  7 days

• Abdominal compartment syndrome

  Enrollment through hospital discharge or 28 days

• In-hospital mortality

  Enrollment through hospital discharge or 28 days

Study Arms (2)

Early Plasma Resuscitation

EXPERIMENTAL

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)%.

Biological: Plasma

Standard Care

ACTIVE COMPARATOR

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

Biological: Standard care

Interventions

Plasma BIOLOGICAL

urgent release early plasma resuscitation following burn/thermal injury

Early Plasma Resuscitation

Standard care BIOLOGICAL

Standard resuscitation as dictated by institutional protocol

Standard Care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jason Sperry: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Burns

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jason Sperry, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason Sperry, MD

CONTACT

4128028270; sperryjl@upmc.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: permuted block design with variable block sizes of 4 and 6, stratified by site

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: October 8, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): May 1, 2030
• Last Updated: May 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will become available after publication of the primary manuscript
• Access Criteria: Requests for data will be submitted in writing and reviewed by the Principal Investigator.

Locations

US (1)