Randomized Trial of Fresh Frozen Plasma Versus Albumin in Acute Burn Resuscitation (FFP)
Primary Purpose
Burns
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fresh Frozen Plasma
Sponsored by

About this trial
This is an interventional treatment trial for Burns focused on measuring Burn resuscitation
Eligibility Criteria
Inclusion Criteria:
- adult thermal injury patients aged 2:18 years old with burns ->20% TBSA seen at UCH Burn Center within 8 hours of burn injury
Exclusion Criteria:
- Pregnant patients, prisoners, Jehovah's Witness/inability to receive human blood product/component therapy, electrical injury, chemical injury, friction/shear injury, anticipated death within 48 hours of admission, delayed intervention (>8 hours post burn), history of renal failure requiring dialysis, Stage IV or V chronic kidney disease, coagulopathy (admission INR >2.5), cirrhosis (Childs B,C), concomitant life threatening traumatic injuries, receiving blood product transfusion for another reason, inability to obtain consent from patient or legally authorized representative.
Sites / Locations
- University of Colorado Denver Anschutz Medical CampusRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Fresh Frozen Plasma
Albumin
Arm Description
At 6-8 hours, Initiate FFP infusion
At 7 hours, Initiate 5% Albumin infusion
Outcomes
Primary Outcome Measures
Total volume of fluid administered in 24 hours in each group (FFP or albumin), measured as mL/kg/%TBSA burned.
Total volume
Secondary Outcome Measures
Full Information
NCT ID
NCT05069922
First Posted
September 27, 2021
Last Updated
April 13, 2023
Sponsor
University of Colorado, Denver
Collaborators
United States Department of Defense
1. Study Identification
Unique Protocol Identification Number
NCT05069922
Brief Title
Randomized Trial of Fresh Frozen Plasma Versus Albumin in Acute Burn Resuscitation
Acronym
FFP
Official Title
Randomized Trial of Fresh Frozen Plasma Versus Albumin in Acute Burn Resuscitation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 17, 2022 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
United States Department of Defense
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators propose a prospective randomized trial to study fresh frozen plasma (FFP) versus albumin to determine the optimal colloid in burn resuscitations. This work addresses both FY20 focus areas, prolonged field care (PFC) and en route care, along with mitigating secondary effects of acute intervention, such as prevention of over resuscitation. Future military conflicts anticipate more extensive burn and blast injuries, and delayed evacuation. Therefore, the direct comparison of colloids used in burn resuscitation is critical to advancing battlefield medicine. Specifically, this work will provide the foundation for the use of freeze-dried plasma (FDP) in burn care by medical responders in PFC and en route care scenarios. The investigators hypothesize that FFP administration, and later FDP, in burn resuscitation is as safe as albumin, and more efficacious, in both reducing the total volume of fluid required in acute burn resuscitation and correcting burn endotheliopathy.
Detailed Description
Specific Aim 1: The investigators will evaluate the total fluids administered in FFP (intervention) and albumin (control) groups. The investigators propose that the FFP group will require less total fluids administered.
Specific Aim 2:The investigators will determine overall complication rates (pulmonary complications, ARDS, ACS, over-resuscitation) in the FFP (intervention) and albumin (control) administration groups. The investigators propose FFP administration will reduce the frequency of these complications.
Specific Aim 3: The investigators will characterize the effects of FFP and albumin administration on endothelial dysfunction in major burns. We will measure glycocalyx degradation products (e.g. syndecan-1, glycosaminoglycans) in the serum. The investigators project FFP will mitigate GDP better than albumin.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
Keywords
Burn resuscitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fresh Frozen Plasma
Arm Type
Active Comparator
Arm Description
At 6-8 hours, Initiate FFP infusion
Arm Title
Albumin
Arm Type
Active Comparator
Arm Description
At 7 hours, Initiate 5% Albumin infusion
Intervention Type
Other
Intervention Name(s)
Fresh Frozen Plasma
Other Intervention Name(s)
Albumin
Intervention Description
Fresh Frozen Plasma
Primary Outcome Measure Information:
Title
Total volume of fluid administered in 24 hours in each group (FFP or albumin), measured as mL/kg/%TBSA burned.
Description
Total volume
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult thermal injury patients aged 2:18 years old with burns ->20% TBSA seen at UCH Burn Center within 8 hours of burn injury
Exclusion Criteria:
Pregnant patients, prisoners, Jehovah's Witness/inability to receive human blood product/component therapy, electrical injury, chemical injury, friction/shear injury, anticipated death within 48 hours of admission, delayed intervention (>8 hours post burn), history of renal failure requiring dialysis, Stage IV or V chronic kidney disease, coagulopathy (admission INR >2.5), cirrhosis (Childs B,C), concomitant life threatening traumatic injuries, receiving blood product transfusion for another reason, inability to obtain consent from patient or legally authorized representative.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Blaire Balstad, BA
Phone
303-724-7803
Email
blaire.balstad@cuanschutz.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Tracey MacDermott
Phone
303-724-2757
Email
tracey.macdermott@cuanschutz.edu
Facility Information:
Facility Name
University of Colorado Denver Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Blaire Balstad
Phone
303-724-7803
Email
blaire.balstad@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Tracey MacDermott
Phone
303-724-2757
Email
tracey.macdermott@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Arek Wiktor, MD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data will be compiled and shared with Department of Defense
Learn more about this trial
Randomized Trial of Fresh Frozen Plasma Versus Albumin in Acute Burn Resuscitation
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