Comparing Fresh Frozen Plasma and Albumin for Burn Treatment
Randomized Trial of Fresh Frozen Plasma Versus Albumin in Acute Burn Resuscitation
This study is testing whether fresh frozen plasma or albumin is better for helping people with severe burns recover and avoid complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT05069922 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of fresh frozen plasma (FFP) compared to albumin in the resuscitation of patients with severe burns. It aims to determine which colloid leads to better outcomes in terms of total fluid volume required and complication rates, such as pulmonary issues and over-resuscitation. The study will also assess the impact of these treatments on endothelial dysfunction in burn patients. By focusing on these factors, the research seeks to improve burn care in both military and civilian settings.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 years and older with burns covering more than 20% of their total body surface area, treated within 8 hours of injury.
Not a fit: Patients with specific exclusions such as pregnant individuals, those with certain types of injuries, or those unable to receive blood products will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for burn victims, potentially reducing complications and fluid requirements.
How similar studies have performed: While this approach is critical for advancing burn care, it builds on existing knowledge, and similar studies have shown promise in optimizing fluid resuscitation strategies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Aurora, Colorado
- University of Colorado Denver Anschutz Medical Campus — Aurora, Colorado, United States (Recruiting)
Study contacts
- Study coordinator: Blaire Balstad, BA
- Email: blaire.balstad@cuanschutz.edu
- Phone: 303-724-7803
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.