Plasma Resuscitation Without Lung Injury

Phase 4

Terminated

• Conditions: Burns
• Interventions: Drug: Crystalloid Solutions; Drug: Pathogen-Reduced Plasma

• Registration Number: NCT04681638
• Lead Sponsor: Coalition for National Trauma Research

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-04
• Study First Submitted QC: 2020-12-19
• Study First Posted: 2020-12-23
• Study Start: 2022-08-17
• Primary Completion: 2024-06-29
• Study Completion: 2024-09-29
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Crystalloid	Crystalloid Solutions	Standardized crystalloid resuscitation
Plasma	Pathogen-Reduced Plasma	Pathogen-Reduced Plasma resuscitation

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Total resuscitation volume in ml/kg	48 hours	The total volume of all resuscitation fluids delivered between hours 0-48 postburn, in ml/kg
Total 24 hour resuscitation volume in ml/kg/TBSA	24 hours	The total volume of all resuscitation fluids delivered between hours 0-24 postburn, in ml/kg/TBSA
Total 48 hour resuscitation volume in ml/kg/TBSA	48 hours	The total volume of all resuscitation fluids delivered between hours 0-48 postburn, in ml/kg/TBSA
Metabolic acidosis	48 hours	Severity and duration of metabolic acidosis (arterial lactate levels)
Hemodynamic instability	48 hours	Severity and duration of hemodynamic instability during hours 0-48 postburn (norepinephrine equivalents)
Incidence of "rescue" (b)	48 hours	Infusion of high-dose ascorbic acid (66 mg/kg/hr)
Incidence of "rescue" (a)	48 hours	Initiation of extracorporeal therapy (continuous renal replacement therapy or therapeutic plasma exchange
Acute Respiratory Distress Syndrome	7 days	Incidence of Acute Respiratory Distress Syndrome using Berlin Criteria
Cytokines	48 hours	Cytokines
Incidence of "rescue" (c)	24 hours	Initiation of a continuous infusion of albumin
Mechanical ventilation	28 days	Ventilator free days
Intensive Care Unit days	28 days	Intensive Care Unit free days
Multi-Organ Failure Assessment	7 days	Sequential Organ Failure Assessment scores. Minimum score 1, maximum score 4. The higher the score the worse the outcome.
Thromboembolic events	7 days	Incidence of venous thrombosis-embolic events (deep vein thrombosis or pulmonary embolism)
Patient reported outcomes	6 months	Patient reported outcomes using the Patient Reported Outcomes Measurement Information System, Global 10. This scale10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. Higher scores equal a healthier patient.
Syndecan-1 levels	48 hours	Syndecan-1 level in ng/dl
Transfusion-Related Acute Lung Injury	72 hours	Incidence of Transfusion-Related Acute Lung Injury, Type I or II.
Mortality	throughout study completion, an average of 1 year	In hospital mortality

Trial Locations

Locations (6)

University of Alabama at Birmingham Burn Center; 🇺🇸 Birmingham, Alabama, United States

University of Maryland School of Medicine; 🇺🇸 Baltimore, Maryland, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

U.S. Army Burn Center; 🇺🇸 Fort Sam Houston, Texas, United States

University of Texas Medical Branch; 🇺🇸 Galveston, Texas, United States

University of Washington School of Medicine; 🇺🇸 Seattle, Washington, United States