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

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

Fresh Frozen Plasma

February 17, 2022

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
Site Not Available
University of Colorado Denver Anschutz Medical Campus
Aurora 5412347, Colorado 5417618 80045
United States
Site Not Available

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