Plasma Resuscitation Without Lung Injury
Stopped early · Phase 4
Conditions studied: Burns
In brief
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, especially the lungs and kidneys, and even in death. In this study, the investigators propose to use plasma, a specially prepared blood product made from the liquid part of blood, that has undergone special treatment to reduce the risk of disease transmission. The aims include 1) reduce the amount of fluid given during the first 24 hours after a burn 2) reduce the incidence of lung injury and other complications related to the administration of funds and 3) determine if the blood product has any effect on inflammation. An overall decrease the amount of fluids that burn patients receive should decrease the potential for lung injury, decrease days in the hospital, and improve survival.
Key facts
- Study ID
- NCT04681638
- Run by
- Coalition for National Trauma Research
- People needed
- 13
- Starts
- 2022-08-17
- Expected to finish
- 2024-09-29
- Last updated by the study team
- 2025-01-29
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Alabama at Birmingham Burn Center — Birmingham, Alabama, United States
- University of Maryland School of Medicine — Baltimore, Maryland, United States
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
- U.S. Army Burn Center — Fort Sam Houston, Texas, United States
- University of Texas Medical Branch — Galveston, Texas, United States
- University of Washington School of Medicine — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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