Status:
TERMINATED
Plasma Resuscitation Without Lung Injury
Lead Sponsor:
Coalition for National Trauma Research
Collaborating Sponsors:
Cerus Corporation
Conditions:
Burns
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The treatment of patients with major burns requires resuscitation with massive amounts of fluid, typically a type of salt water that is given by vein. This frequently results in injury to vital organs...
Eligibility Criteria
Inclusion
- Age \> 18 years
- Weight \> 40 kg
- Initial assessment of thermal injury size ≥ 20% TBSA
- Admitted to the burn center and enroll able within 8 hours of injury
- Expected to receive intravenous resuscitation fluids for at least 24 hours after injury
- Expected to live \> 24 hours after injury
Exclusion
- Chemical injury
- Deep electric injury
- Associated non-thermal injuries with estimated Injury Severity Score \> 25
- Inability to obtain informed consent
- Decision not to treat due to injury severity or other factors
- Patient age \> 65 years or \< 18 years
- Presence of anoxic brain injury that is not expected to result in complete recover
- Patent already receiving plasma infusion, or judged to be likely to require plasma infusion
- Patent already receiving "rescue procedures" (albumin infusion, CRRT, TPE, or high-dose ascorbic acid)
- Existence of pre-morbid conditions: Congestive heart failure (NYHA Class IV); End-stage kidney disease (dialysis patient); Cirrhosis of the liver; Oxygen-dependent chronic obstructive pulmonary disease; Malignancy currently under treatment; Previous bilateral lower extremity amputations
Key Trial Info
Start Date :
August 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 29 2024
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04681638
Start Date
August 17 2022
End Date
September 29 2024
Last Update
January 29 2025
Active Locations (6)
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1
University of Alabama at Birmingham Burn Center
Birmingham, Alabama, United States, 35294
2
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
3
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
4
U.S. Army Burn Center
Fort Sam Houston, Texas, United States, 78234-6315