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

NCT05069922 | Completed

• 2 other identifiers: 21-3710CDMRP-MB200032
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns

Keywords

Burn resuscitation

Outcome Measures

Primary Outcomes (1)

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

  Total volume

  3 years

Study Arms (2)

Fresh Frozen Plasma

ACTIVE COMPARATOR

At 6-8 hours, Initiate FFP infusion

Other: Fresh Frozen Plasma

Albumin

ACTIVE COMPARATOR

At 7 hours, Initiate 5% Albumin infusion

Other: Fresh Frozen Plasma

Interventions

Fresh Frozen Plasma OTHER

Fresh Frozen Plasma

Also known as: Albumin

Albumin; Fresh Frozen Plasma

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of Colorado Denver Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Burns

Interventions

Albumins

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 6, 2021
• Study Start: February 17, 2022
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)