Plasma Resuscitation Without Lung Injury (PROPOLIS)
Primary Purpose
Burns
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pathogen-Reduced Plasma
Crystalloid Solutions
Sponsored by
About this trial
This is an interventional treatment trial for Burns
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
Sites / Locations
- University of Alabama at Birmingham Burn CenterRecruiting
- University of Maryland School of Medicine
- Vanderbilt University Medical CenterRecruiting
- University of Texas Southwestern
- U.S. Army Burn CenterRecruiting
- University of Texas Medical Branch
- University of Washington School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Plasma
Crystalloid
Arm Description
Pathogen-Reduced Plasma resuscitation
Standardized crystalloid resuscitation
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Total resuscitation volume in ml/kg
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
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
The total volume of all resuscitation fluids delivered between hours 0-48 postburn, in ml/kg/TBSA
Hemodynamic instability
Severity and duration of hemodynamic instability during hours 0-48 postburn (norepinephrine equivalents)
Metabolic acidosis
Severity and duration of metabolic acidosis (arterial lactate levels)
Incidence of "rescue" (a)
Initiation of extracorporeal therapy (continuous renal replacement therapy or therapeutic plasma exchange
Incidence of "rescue" (b)
Infusion of high-dose ascorbic acid (66 mg/kg/hr)
Incidence of "rescue" (c)
Initiation of a continuous infusion of albumin
Acute Respiratory Distress Syndrome
Incidence of Acute Respiratory Distress Syndrome using Berlin Criteria
Mechanical ventilation
Ventilator free days
Intensive Care Unit days
Intensive Care Unit free days
Multi-Organ Failure Assessment
Sequential Organ Failure Assessment scores. Minimum score 1, maximum score 4. The higher the score the worse the outcome.
Transfusion-Related Acute Lung Injury
Incidence of Transfusion-Related Acute Lung Injury, Type I or II.
Thromboembolic events
Incidence of venous thrombosis-embolic events (deep vein thrombosis or pulmonary embolism)
Mortality
In hospital mortality
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.
Syndecan-1 levels
Syndecan-1 level in ng/dl
Cytokines
Cytokines
Full Information
NCT ID
NCT04681638
First Posted
December 4, 2020
Last Updated
September 6, 2023
Sponsor
Coalition for National Trauma Research
Collaborators
Cerus Corporation
1. Study Identification
Unique Protocol Identification Number
NCT04681638
Brief Title
Plasma Resuscitation Without Lung Injury
Acronym
PROPOLIS
Official Title
Plasma Resuscitation withOut Lung Injury
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 17, 2022 (Actual)
Primary Completion Date
June 29, 2024 (Anticipated)
Study Completion Date
September 29, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coalition for National Trauma Research
Collaborators
Cerus Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Plasma
Arm Type
Experimental
Arm Description
Pathogen-Reduced Plasma resuscitation
Arm Title
Crystalloid
Arm Type
Active Comparator
Arm Description
Standardized crystalloid resuscitation
Intervention Type
Drug
Intervention Name(s)
Pathogen-Reduced Plasma
Other Intervention Name(s)
PRP
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Crystalloid Solutions
Other Intervention Name(s)
LR
Intervention Description
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.
Primary Outcome Measure Information:
Title
The total volume of all resuscitation fluids delivered between hours 0-24 postern, in ml/kg.
Description
The total volume of all resuscitation fluids delivered between hours 0-24 postburn, in ml/kg
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Total resuscitation volume in ml/kg
Description
The total volume of all resuscitation fluids delivered between hours 0-48 postburn, in ml/kg
Time Frame
48 hours
Title
Total 24 hour resuscitation volume in ml/kg/TBSA
Description
The total volume of all resuscitation fluids delivered between hours 0-24 postburn, in ml/kg/TBSA
Time Frame
24 hours
Title
Total 48 hour resuscitation volume in ml/kg/TBSA
Description
The total volume of all resuscitation fluids delivered between hours 0-48 postburn, in ml/kg/TBSA
Time Frame
48 hours
Title
Hemodynamic instability
Description
Severity and duration of hemodynamic instability during hours 0-48 postburn (norepinephrine equivalents)
Time Frame
48 hours
Title
Metabolic acidosis
Description
Severity and duration of metabolic acidosis (arterial lactate levels)
Time Frame
48 hours
Title
Incidence of "rescue" (a)
Description
Initiation of extracorporeal therapy (continuous renal replacement therapy or therapeutic plasma exchange
Time Frame
48 hours
Title
Incidence of "rescue" (b)
Description
Infusion of high-dose ascorbic acid (66 mg/kg/hr)
Time Frame
48 hours
Title
Incidence of "rescue" (c)
Description
Initiation of a continuous infusion of albumin
Time Frame
24 hours
Title
Acute Respiratory Distress Syndrome
Description
Incidence of Acute Respiratory Distress Syndrome using Berlin Criteria
Time Frame
7 days
Title
Mechanical ventilation
Description
Ventilator free days
Time Frame
28 days
Title
Intensive Care Unit days
Description
Intensive Care Unit free days
Time Frame
28 days
Title
Multi-Organ Failure Assessment
Description
Sequential Organ Failure Assessment scores. Minimum score 1, maximum score 4. The higher the score the worse the outcome.
Time Frame
7 days
Title
Transfusion-Related Acute Lung Injury
Description
Incidence of Transfusion-Related Acute Lung Injury, Type I or II.
Time Frame
72 hours
Title
Thromboembolic events
Description
Incidence of venous thrombosis-embolic events (deep vein thrombosis or pulmonary embolism)
Time Frame
7 days
Title
Mortality
Description
In hospital mortality
Time Frame
throughout study completion, an average of 1 year
Title
Patient reported outcomes
Description
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
Title
Syndecan-1 levels
Description
Syndecan-1 level in ng/dl
Time Frame
48 hours
Title
Cytokines
Description
Cytokines
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monica Phillips, MBA
Phone
210-884-3410
Email
monica@nattrauma.org
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle Price, PhD
Phone
210-455-8038
Email
michelle@nattrauma.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leopoldo Cancio, MD
Organizational Affiliation
U.S. Army Burn Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham Burn Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shannon Stephens
Phone
205-934-5890
Email
swstephens@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Jan Jensen, MBBS, Phd
Facility Name
University of Maryland School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosemary Kozar, MD
Phone
410-328-3495
Email
rkozar@som.umaryland.edu
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Folliard, BSN
Phone
615-936-2876
Email
sarah.folliard@vumc.org
First Name & Middle Initial & Last Name & Degree
Robel Beyene, MD
Facility Name
University of Texas Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Withdrawn
Facility Name
U.S. Army Burn Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234-6315
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shannon Gutierrez, BSN
Phone
210-916-0990
Email
shannon.gutierrez4.ctr@health.mil
First Name & Middle Initial & Last Name & Degree
Leopoldo Cancio, MD
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Hennessy
Email
eahennes@utmb.edu
First Name & Middle Initial & Last Name & Degree
Steven Wolf, MD
Facility Name
University of Washington School of Medicine
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104-2499
Country
United States
Individual Site Status
Active, not recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
Data will become available one year after initial results publication.
Learn more about this trial
Plasma Resuscitation Without Lung Injury
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