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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

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

Locations
United States
Colorado
University of Colorado Denver Anschutz Medical Campus
RECRUITING
Aurora
Contact Information
Primary
Blaire Balstad, BA
blaire.balstad@cuanschutz.edu
303-724-7803
Backup
Tracey MacDermott
tracey.macdermott@cuanschutz.edu
303-724-2757
Time Frame
Start Date: 2022-02-17
Estimated Completion Date: 2025-08-31
Participants
Target number of participants: 100
Treatments
Active_comparator: Fresh Frozen Plasma
At 6-8 hours, Initiate FFP infusion
Active_comparator: Albumin
At 7 hours, Initiate 5% Albumin infusion
Related Therapeutic Areas
Sponsors
Collaborators: United States Department of Defense
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov