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

ArmDescriptionAssigned Intervention
Experimental
Plasma 		Pathogen-Reduced Plasma resuscitation
  • Drug: Pathogen-Reduced Plasma
    The treatment group will receive an additional infusion of Pathogen-Reduced Plasma based on the formula, hourly rate, mL/hr = (1 mL*kg*TBSA)/24 hr. This infusion will not be titrated. It will be discontinued at the end of the 24th postburn hour.
    Other names:
    • PRP
Active Comparator
Crystalloid 		Standardized crystalloid resuscitation
  • Drug: Crystalloid Solutions
    The control group will receive an additional infusion of LR based on the formula: hourly rate, mL/hr = (1mL*kg*TBSA)/24 hr. this infusion will not be titrated. It will be discontinued at the end of the 24th postburn hour.
    Other names:
    • LR

Recruiting Locations

University of Alabama at Birmingham Burn Center
Birmingham, Alabama 35294
Contact:
Shannon Stephens
205-934-5890
swstephens@uabmc.edu

More Details

Status
Recruiting
Sponsor
Coalition for National Trauma Research

Study Contact

Monica Phillips, MBA
210-884-3410
monica@nattrauma.org