Plasma Resuscitation Without Lung Injury
Purpose
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.
Condition
- Burns
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- This is an open-label, phase IV, multicenter, randomized controlled prospective clinical trial in patients with burns. The study model is parallel (between-patient). The intervention to be tested is Pathogen-Reduced Plasma for burn shock resuscitation vs. standard-of-care resuscitation.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Plasma |
Pathogen-Reduced Plasma resuscitation |
|
|
Active Comparator Crystalloid |
Standardized crystalloid resuscitation |
|
Recruiting Locations
Birmingham, Alabama 35294
More Details
- Status
- Recruiting
- Sponsor
- Coalition for National Trauma Research