Plasma Resuscitation Without Lung Injury (NCT04681638) | Clinical Trial Compass
TerminatedPhase 4
Plasma Resuscitation Without Lung Injury
Stopped: Enrollment targets were unable to be reached due to difficulty in locating and contacting the Legally Authorized Representative (LAR). Even with prolonged enrollment timeframe, the study was unable to obtain consent from the LAR.
United States13 participantsStarted 2022-08-17
Plain-language 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, 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The total volume of all resuscitation fluids delivered between hours 0-24 postern, in ml/kg.