Plasma Resuscitation Without Lung Injury

Burns Clinical Trial

— PROPOLIS  

Official title:

Plasma Resuscitation withOut Lung Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04681638
• Other study ID #: CNTR-2020-001
• Secondary ID: CDMRP-DM190167
• Status: Recruiting
• Phase: Phase 4
• Start date: August 17, 2022
• Est. completion date: September 29, 2024

Study information

• Verified date: September 2023
• Source: Coalition for National Trauma Research
• Contact: Monica Phillips, MBA
• Phone: 210-884-3410
• Email: monica[@]nattrauma.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: September 29, 2024
• Est. primary completion date: June 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Burns
• Lung Injury

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Maryland School of Medicine	Baltimore	Maryland
United States	University of Alabama at Birmingham Burn Center	Birmingham	Alabama
United States	University of Texas Southwestern	Dallas	Texas
United States	U.S. Army Burn Center	Fort Sam Houston	Texas
United States	University of Texas Medical Branch	Galveston	Texas
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	University of Washington School of Medicine	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Coalition for National Trauma Research	Cerus Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total resuscitation volume in ml/kg	The total volume of all resuscitation fluids delivered between hours 0-48 postburn, in ml/kg	48 hours
Secondary	Total 24 hour resuscitation volume in ml/kg/TBSA	The total volume of all resuscitation fluids delivered between hours 0-24 postburn, in ml/kg/TBSA	24 hours
Secondary	Total 48 hour resuscitation volume in ml/kg/TBSA	The total volume of all resuscitation fluids delivered between hours 0-48 postburn, in ml/kg/TBSA	48 hours
Secondary	Hemodynamic instability	Severity and duration of hemodynamic instability during hours 0-48 postburn (norepinephrine equivalents)	48 hours
Secondary	Metabolic acidosis	Severity and duration of metabolic acidosis (arterial lactate levels)	48 hours
Secondary	Incidence of "rescue" (a)	Initiation of extracorporeal therapy (continuous renal replacement therapy or therapeutic plasma exchange	48 hours
Secondary	Incidence of "rescue" (b)	Infusion of high-dose ascorbic acid (66 mg/kg/hr)	48 hours
Secondary	Incidence of "rescue" (c)	Initiation of a continuous infusion of albumin	24 hours
Secondary	Acute Respiratory Distress Syndrome	Incidence of Acute Respiratory Distress Syndrome using Berlin Criteria	7 days
Secondary	Mechanical ventilation	Ventilator free days	28 days
Secondary	Intensive Care Unit days	Intensive Care Unit free days	28 days
Secondary	Multi-Organ Failure Assessment	Sequential Organ Failure Assessment scores. Minimum score 1, maximum score 4. The higher the score the worse the outcome.	7 days
Secondary	Transfusion-Related Acute Lung Injury	Incidence of Transfusion-Related Acute Lung Injury, Type I or II.	72 hours
Secondary	Thromboembolic events	Incidence of venous thrombosis-embolic events (deep vein thrombosis or pulmonary embolism)	7 days
Secondary	Mortality	In hospital mortality	throughout study completion, an average of 1 year
Secondary	Patient reported outcomes	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.	6 months
Secondary	Syndecan-1 levels	Syndecan-1 level in ng/dl	48 hours
Secondary	Cytokines	Cytokines	48 hours