Plasma Resuscitation Without Lung Injury

NCT04681638 | Terminated Phase 4 DMC FDA Drug

• 2 other identifiers: CNTR-2020-001CDMRP-DM190167
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 6

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, 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.

Conditions

Burns

Outcome Measures

Primary Outcomes (1)

• The total volume of all resuscitation fluids delivered between hours 0-24 postern, in ml/kg.

  The total volume of all resuscitation fluids delivered between hours 0-24 postburn, in ml/kg

  24 hours

Secondary Outcomes (18)

• Total resuscitation volume in ml/kg

  48 hours

• Total 24 hour resuscitation volume in ml/kg/TBSA

  24 hours

• Total 48 hour resuscitation volume in ml/kg/TBSA

  48 hours

• Hemodynamic instability

  48 hours

• Metabolic acidosis

  48 hours

Study Arms (2)

Plasma

EXPERIMENTAL

Pathogen-Reduced Plasma resuscitation

Drug: Pathogen-Reduced Plasma

Crystalloid

ACTIVE COMPARATOR

Standardized crystalloid resuscitation

Drug: Crystalloid Solutions

Interventions

Pathogen-Reduced Plasma DRUG

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.

Also known as: PRP

Plasma

Crystalloid Solutions DRUG

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.

Also known as: LR

Crystalloid

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Coalition for National Trauma Research: lead
• Cerus Corporation: collaborator

Study Sites (6)

University of Alabama at Birmingham Burn Center

Birmingham, Alabama, 35294, United States

Location

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

U.S. Army Burn Center

Fort Sam Houston, Texas, 78234-6315, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

University of Washington School of Medicine

Seattle, Washington, 98104-2499, United States

Location

MeSH Terms

Conditions

Burns

Interventions

Crystalloid Solutions

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Leopoldo Cancio, MD

  U.S. Army Burn Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 23, 2020
• Study Start: August 17, 2022
• Primary Completion: June 29, 2024
• Study Completion: September 29, 2024
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will become available one year after initial results publication.

Locations

US (6)