REPlaCE- Randomized Trial Evaluating the Use of Prothrombin Complex concEntrate to Improve Survival in Patients With Traumatic Coagulopathy
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 280
- Primary Endpoint
- 24 Hour Mortality
Study Overview
Brief Summary
Uncontrolled hemorrhage continues to be a significant source of mortality for trauma patients. Their condition is further complicated by Trauma Induced Coagulopathy (TIC), which makes it more difficult to control bleeding due to coagulation factor deficiency. Prothrombin Complex Concentrate (PCC) is thought to be a promising treatment option. This phase II clinical trial evaluates the use of 4-Factor PCC in addition to standard resuscitation methods compared to standard resuscitation methods alone in patients with TIC. Patients will be randomized at a 1:1 ratio. The primary endpoint of this trial will be 30 day mortality.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 15 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •≥15 years old
- •anticipate giving 4+ units based on Revised Assessment of Bleeding and Transfusion score ≥ 2
Exclusion Criteria
- •Cardiopulmonary Resuscitation > 5 minutes
- •Penetrating cranial injury or exposed brain matter
- •Anticoagulation treatment
- •Transfer patients
- •Known pregnancy
Arms & Interventions
Standard of Care
standard resuscitation methods only
Intervention: Whole Blood, Plasma, Packed Red Blood Cells (Biological)
PCC
single dose of 4-Factor PCC in addition to standard resuscitation methods
Intervention: Prothrombin Complex Concentrate (Biological)
Outcomes
Primary Outcomes
24 Hour Mortality
Time Frame: 24 hours after enrollment
Assess if patient is alive at 24 hours post treatment
Secondary Outcomes
No secondary outcomes reported
Investigators
Bellal A. Joseph, MD, FACS
Chief of the Division of Trauma, Acute Care, Burn, and Emergency Surgery
University of Arizona