Clinical trial NCT04681638: Plasma Resuscitation Without Lung Injury
Official title: Plasma Resuscitation withOut Lung Injury
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Burns
Lead sponsor: Coalition for National Trauma Research
Sponsor class: OTHER
Collaborators: name: Cerus Corporation
First posted: 2020-12-23
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The total volume of all resuscitation fluids delivered between hours 0-24 postern, in ml/kg.
timeFrame: 24 hours
Secondary outcomes:
measure: Total resuscitation volume in ml/kg
timeFrame: 48 hours
measure: Total 24 hour resuscitation volume in ml/kg/TBSA
timeFrame: 24 hours
measure: Total 48 hour resuscitation volume in ml/kg/TBSA
timeFrame: 48 hours
measure: Hemodynamic instability
timeFrame: 48 hours
measure: Metabolic acidosis
timeFrame: 48 hours
measure: Incidence of "rescue" (a)
timeFrame: 48 hours
measure: Incidence of "rescue" (b)
timeFrame: 48 hours
measure: Incidence of "rescue" (c)
timeFrame: 24 hours
measure: Acute Respiratory Distress Syndrome
timeFrame: 7 days
measure: Mechanical ventilation
timeFrame: 28 days
measure: Intensive Care Unit days
timeFrame: 28 days
measure: Multi-Organ Failure Assessment
timeFrame: 7 days
measure: Transfusion-Related Acute Lung Injury
timeFrame: 72 hours
measure: Thromboembolic events
timeFrame: 7 days
measure: Mortality
timeFrame: throughout study completion, an average of 1 year
measure: Patient reported outcomes
timeFrame: 6 months
measure: Syndecan-1 levels
timeFrame: 48 hours
measure: Cytokines
timeFrame: 48 hours
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Burn Center
state: Alabama
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Fort Sam Houston
country: United States
facility: U.S. Army Burn Center
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Seattle
country: United States
facility: University of Washington School of Medicine
state: Washington
Study officials:
affiliation: U.S. Army Burn Center
name: Leopoldo Cancio, MD
role: PRINCIPAL_INVESTIGATOR
References: