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

Jason Sperry

Status and phase: Begins enrollment in 1 month; Phase 3

Conditions: Thermal Burn; Burn Injury

Treatments: Biological: Standard care; Biological: Plasma

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT07212998

STUDY25030138

HT9425-24-3-0002 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 750 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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750 participants in 2 patient groups

Early Plasma Resuscitation

Experimental group

Description:

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)%.

Treatment:

Biological: Plasma

Standard Care

Active Comparator group

Description:

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

Treatment:

Biological: Standard care