NCT03981484

REPlaCE- Randomized Trial Evaluating the Use of Prothrombin Complex concEntrate to Improve Survival in Patients With Traumatic Coagulopathy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: Bellal A. Joseph, MD, FACS · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coagulopathy
• Hemorrhage

Interventions

Type	Name	Description
BIOLOGICAL	Prothrombin Complex Concentrate	single dose of 25 IU/kg of 4-PCC at time of enrollment
BIOLOGICAL	Whole Blood, Plasma, Packed Red Blood Cells	site's standard resuscitation protocol

Timeline

• Start date: 2020-01-01
• Primary completion: 2022-10-01
• Completion: 2023-01-01
• First posted: 2019-06-10
• Last updated: 2019-06-10