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

Last updated: May 10, 2024
Sponsor: University of Colorado, Denver
Overall Status: Active - Recruiting

Phase

N/A

Condition

Skin Wounds

Hyponatremia

Treatment

Fresh Frozen Plasma

Clinical Study ID

NCT05069922
21-3710
CDMRP-MB200032
  • Ages 18-100
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • adult thermal injury patients aged 2:18 years old with burns ->20% TBSA seen at UCHBurn Center within 8 hours of burn injury

Exclusion

Exclusion Criteria:

  • Pregnant patients, prisoners, Jehovah's Witness/inability to receive human bloodproduct/component therapy, electrical injury, chemical injury, friction/shearinjury, anticipated death within 48 hours of admission, delayed intervention (>8hours post burn), history of renal failure requiring dialysis, Stage IV or V chronickidney disease, coagulopathy (admission INR >2.5), cirrhosis (Childs B,C),concomitant life threatening traumatic injuries, receiving blood product transfusionfor another reason, inability to obtain consent from patient or legally authorizedrepresentative.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Fresh Frozen Plasma
Phase:
Study Start date:
February 17, 2022
Estimated Completion Date:
August 31, 2025

Study 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.

Connect with a study center

  • University of Colorado Denver Anschutz Medical Campus

    Aurora, Colorado 80045
    United States

    Active - Recruiting

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