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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
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns focused on measuring Burn resuscitation

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 27, 2021
Last Updated
April 13, 2023
Sponsor
University of Colorado, Denver
Collaborators
United States Department of Defense
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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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