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Plasma Resuscitation Without Lung Injury | Clinical Trials | Clareo Health

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TERMINATEDPhase 4NCT04681638

Plasma Resuscitation Without Lung Injury

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...

Lead sponsor: Coalition for National Trauma Research•6 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Coalition for National Trauma Research

Collaborators

Cerus Corporation

Age

18 - 65 years

Sex

ALL

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: January 29, 2025Terms

Trial snapshot

StatusTERMINATED

PhasePHASE4

Enrollment13

Start dateAug 2022

Last updatedJan 29, 2025

Condition

Locations shown

University of Alabama at Birmingham Burn Center

Birmingham, Alabama

University of Maryland School of Medicine

Baltimore, Maryland

Vanderbilt University Medical Center

Nashville, Tennessee

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 29, 2025Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions