A Phase 4 interventional study of Pathogen-Reduced Plasma and Crystalloid Solutions in Burns, sponsored by Coalition for National Trauma Research. Terminated at 6 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-01-29.
Sponsored by Coalition for National Trauma Research · Phase 4, Interventional, and Treatment
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.
399 studies on the registry are indexed under Lung Injury; 50 are open to participants now.
This study's enrollment of 13 is below the median of 53 across 239 interventional studies indexed under Lung Injury.
Browse Lung Injury studies →This is the only study on the registry with Coalition for National Trauma Research as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Pathogen-Reduced Plasma resuscitation
Drug: Pathogen-Reduced Plasma
Standardized crystalloid resuscitation
Drug: Crystalloid Solutions
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
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
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
Time frame: 24 hours
Total resuscitation volume in ml/kg
The total volume of all resuscitation fluids delivered between hours 0-48 postburn, in ml/kg
Time frame: 48 hours
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
Time frame: 24 hours
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
Time frame: 48 hours
Hemodynamic instability
Severity and duration of hemodynamic instability during hours 0-48 postburn (norepinephrine equivalents)
Time frame: 48 hours
Metabolic acidosis
Severity and duration of metabolic acidosis (arterial lactate levels)
Time frame: 48 hours
Incidence of "rescue" (a)
Initiation of extracorporeal therapy (continuous renal replacement therapy or therapeutic plasma exchange
Time frame: 48 hours
Incidence of "rescue" (b)
Infusion of high-dose ascorbic acid (66 mg/kg/hr)
Time frame: 48 hours
Incidence of "rescue" (c)
Initiation of a continuous infusion of albumin
Time frame: 24 hours
Acute Respiratory Distress Syndrome
Incidence of Acute Respiratory Distress Syndrome using Berlin Criteria
Time frame: 7 days
Mechanical ventilation
Ventilator free days
Time frame: 28 days
Intensive Care Unit days
Intensive Care Unit free days
Time frame: 28 days
Multi-Organ Failure Assessment
Sequential Organ Failure Assessment scores. Minimum score 1, maximum score 4. The higher the score the worse the outcome.
Time frame: 7 days
Transfusion-Related Acute Lung Injury
Incidence of Transfusion-Related Acute Lung Injury, Type I or II.
Time frame: 72 hours
Thromboembolic events
Incidence of venous thrombosis-embolic events (deep vein thrombosis or pulmonary embolism)
Time frame: 7 days
Mortality
In hospital mortality
Time frame: throughout study completion, an average of 1 year
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.
Time frame: 6 months
Syndecan-1 levels
Syndecan-1 level in ng/dl
Time frame: 48 hours
Cytokines
Cytokines
Time frame: 48 hours
Plan to share: Yes
Supporting information: Study protocol, Sap, Icf
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This study is terminated, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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