Clincosm LogoSign in Get a demo

FFP: Randomized Trial of Fresh Frozen Plasma Versus Albumin in Acute Burn Resuscitation

Sponsor
University of Colorado, Denver (Other)
Overall Status
Recruiting
CT.gov ID
NCT05069922
Collaborator
United States Department of Defense (U.S. Fed)
100
Enrollment
1
Location
2
Arms
30.4
Anticipated Duration (Months)
3.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Fresh Frozen Plasma
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized Trial of Fresh Frozen Plasma Versus Albumin in Acute Burn Resuscitation
Actual Study Start Date :
Feb 17, 2022
Anticipated Primary Completion Date :
Aug 31, 2024
Anticipated Study Completion Date :
Aug 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Fresh Frozen Plasma

At 6-8 hours, Initiate FFP infusion

Other: Fresh Frozen Plasma
Fresh Frozen Plasma
Other Names:
  • Albumin

    		•
    Active Comparator: Albumin

    At 7 hours, Initiate 5% Albumin infusion

    Other: Fresh Frozen Plasma
    Fresh Frozen Plasma
    Other Names:
  • Albumin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Total volume of fluid administered in 24 hours in each group (FFP or albumin), measured as mL/kg/%TBSA burned. [3 years]

      Total volume

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Colorado Denver Anschutz Medical Campus Aurora Colorado United States 80045

    Sponsors and Collaborators

    • University of Colorado, Denver
    • United States Department of Defense

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Colorado, Denver
    ClinicalTrials.gov Identifier:
    NCT05069922
    Other Study ID Numbers:
    • 21-3710
    • CDMRP-MB200032
    First Posted:
    Oct 6, 2021
    Last Update Posted:
    Mar 8, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Colorado, Denver
    Burn resuscitation
    Additional relevant MeSH terms:
    Burns

    Study Results

    No Results Posted as of Mar 8, 2022