NCT07212998

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 750 (estimated)
• Sponsor: Jason Sperry · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	Plasma	urgent release early plasma resuscitation following burn/thermal injury
BIOLOGICAL	Standard care	Standard resuscitation as dictated by institutional protocol

Timeline

• Start date: 2026-04-01
• Primary completion: 2030-04-01
• Completion: 2030-05-01
• First posted: 2025-10-08
• Last updated: 2026-03-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study