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| ID | Type | Description | Link |
|---|---|---|---|
| CDMRP-DM190167 | Other Grant/Funding Number | Department of Defense |
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Enrollment targets were unable to be reached due to difficulty in locating and contacting the Legally Authorized Representative (LAR). Even with prolonged enrollment timeframe, the study was unable to obtain consent from the LAR.
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| Name | Class |
|---|---|
| Cerus Corporation | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plasma | Experimental | Pathogen-Reduced Plasma resuscitation |
|
| Crystalloid | Active Comparator | Standardized crystalloid resuscitation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pathogen-Reduced Plasma | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Total resuscitation volume in ml/kg | The total volume of all resuscitation fluids delivered between hours 0-48 postburn, in ml/kg | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leopoldo Cancio, MD | U.S. Army Burn Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Burn Center | Birmingham | Alabama | 35294 | United States | ||
| University of Maryland School of Medicine |
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Data will become available one year after initial results publication.
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| ID | Term |
|---|---|
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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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.
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| Crystalloid Solutions | Drug | 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. |
|
|
| 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 | 48 hours |
| Hemodynamic instability | Severity and duration of hemodynamic instability during hours 0-48 postburn (norepinephrine equivalents) | 48 hours |
| Metabolic acidosis | Severity and duration of metabolic acidosis (arterial lactate levels) | 48 hours |
| Incidence of "rescue" (a) | Initiation of extracorporeal therapy (continuous renal replacement therapy or therapeutic plasma exchange | 48 hours |
| Incidence of "rescue" (b) | Infusion of high-dose ascorbic acid (66 mg/kg/hr) | 48 hours |
| Incidence of "rescue" (c) | Initiation of a continuous infusion of albumin | 24 hours |
| Acute Respiratory Distress Syndrome | Incidence of Acute Respiratory Distress Syndrome using Berlin Criteria | 7 days |
| Mechanical ventilation | Ventilator free days | 28 days |
| Intensive Care Unit days | Intensive Care Unit free days | 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. | 7 days |
| Transfusion-Related Acute Lung Injury | Incidence of Transfusion-Related Acute Lung Injury, Type I or II. | 72 hours |
| Thromboembolic events | Incidence of venous thrombosis-embolic events (deep vein thrombosis or pulmonary embolism) | 7 days |
| Mortality | In hospital mortality | 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. | 6 months |
| Syndecan-1 levels | Syndecan-1 level in ng/dl | 48 hours |
| Cytokines | Cytokines | 48 hours |
| Baltimore |
| Maryland |
| 21201 |
| United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| U.S. Army Burn Center | Fort Sam Houston | Texas | 78234-6315 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
| University of Washington School of Medicine | Seattle | Washington | 98104-2499 | United States |