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

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.

Study Overview

• Status: Completed
• Conditions: Burns
• Intervention / Treatment: Other: Fresh Frozen Plasma

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 Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver Anschutz Medical Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 96 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total volume of fluid administered in 24 hours in each group (FFP or albumin), measured as mL/kg/%TBSA burned.	Total volume	3 years

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: United States Department of Defense

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2022
• Primary Completion (Actual): August 31, 2025
• Study Completion (Actual): August 31, 2025

Study Registration Dates

• First Submitted: September 27, 2021
• First Submitted That Met QC Criteria: September 27, 2021
• First Posted (Actual): October 6, 2021

Study Record Updates

• Last Update Posted (Estimated): November 13, 2025
• Last Update Submitted That Met QC Criteria: November 11, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Burn resuscitation
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns; Amino Acids, Peptides, and Proteins; Proteins; Albumins
• Other Study ID Numbers: 21-3710; CDMRP-MB200032 (Other Identifier: USAMRAA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be compiled and shared with Department of Defense

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No