Burns
Conditions
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.
Interventions
DRUGPathogen-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.
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.
Sponsors
Cerus Corporation
Coalition for National Trauma Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Cytokines | 48 hours | Cytokines |
| 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 |
| Hemodynamic instability | 48 hours | Severity and duration of hemodynamic instability during hours 0-48 postburn (norepinephrine equivalents) |
| Metabolic acidosis | 48 hours | Severity and duration of metabolic acidosis (arterial lactate levels) |
| Incidence of rescue (a) | 48 hours | Initiation of extracorporeal therapy (continuous renal replacement therapy or therapeutic plasma exchange |
| Incidence of rescue (b) | 48 hours | Infusion of high-dose ascorbic acid (66 mg/kg/hr) |
| Syndecan-1 levels | 48 hours | Syndecan-1 level in ng/dl |
| Acute Respiratory Distress Syndrome | 7 days | Incidence of Acute Respiratory Distress Syndrome using Berlin Criteria |
| 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. |
| Transfusion-Related Acute Lung Injury | 72 hours | Incidence of Transfusion-Related Acute Lung Injury, Type I or II. |
| Thromboembolic events | 7 days | Incidence of venous thrombosis-embolic events (deep vein thrombosis or pulmonary embolism) |
| Mortality | throughout study completion, an average of 1 year | In hospital mortality |
| 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. |
| Incidence of rescue (c) | 24 hours | Initiation of a continuous infusion of albumin |
Countries
United States
Outcome results
None listed