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

Hemorrhage Clinical Trial

— REPLaCE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03981484
• Other study ID #: 00001
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 2020
• Est. completion date: January 2023

Study information

• Verified date: June 2019
• Source: University of Arizona
• Contact: Andrea Seach, BS
• Phone: 520-626-2876
• Email: aseach[@]surgery.arizona.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 280
• Est. completion date: January 2023
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

1. =15 years old

2. anticipate giving 4+ units based on Revised Assessment of Bleeding and Transfusion score = 2

Exclusion Criteria:

1. Cardiopulmonary Resuscitation > 5 minutes

2. Penetrating cranial injury or exposed brain matter

3. Anticoagulation treatment

4. Transfer patients

5. Known pregnancy

6. Prisoners

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Coagulopathy
• Hemorrhage
• Hemostatic Disorders

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bellal A. Joseph, MD, FACS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24 Hour Mortality	Assess if patient is alive at 24 hours post treatment	24 hours after enrollment