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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
permuted block design with variable block sizes of 4 and 6, stratified by site
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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)%.
  • Biological: Plasma
    urgent release early plasma resuscitation following burn/thermal injury
Active Comparator
Standard Care 		Subjects will receive resuscitation following individual site standard burn resuscitation practice.
  • Biological: Standard care
    Standard resuscitation as dictated by institutional protocol

Recruiting Locations

University of Pittsburgh
Pittsburgh, Pennsylvania 15213
Contact:
Jason Sperry, MD
412-647-3065
sperryjl@upmc.edu

More Details

Status
Recruiting
Sponsor
Jason Sperry

Study Contact

Jason Sperry, MD
4128028270
sperryjl@upmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.