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

NCT ID: NCT03981484

Last Updated: 2019-06-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-31
• Study Completion Date: 2023-01-31

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.

Conditions

Coagulopathy; Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

PCC

single dose of 4-Factor PCC in addition to standard resuscitation methods

Group Type: EXPERIMENTAL

Prothrombin Complex Concentrate

Intervention Type: BIOLOGICAL

single dose of 25 IU/kg of 4-PCC at time of enrollment

Standard of Care

standard resuscitation methods only

Group Type: ACTIVE_COMPARATOR

Whole Blood, Plasma, Packed Red Blood Cells

Intervention Type: BIOLOGICAL

site's standard resuscitation protocol

Interventions

Prothrombin Complex Concentrate

single dose of 25 IU/kg of 4-PCC at time of enrollment

Intervention Type: BIOLOGICAL

Whole Blood, Plasma, Packed Red Blood Cells

site's standard resuscitation protocol

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bellal A. Joseph, MD, FACS

OTHER

Sponsor Role: lead

Responsible Party

Bellal A. Joseph, MD, FACS

Chief of the Division of Trauma, Acute Care, Burn, and Emergency Surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Bellal Joseph, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Central Contacts

Andrea Seach, BS

Role: CONTACT

aseach@surgery.arizona.edu

520-626-2876

Other Identifiers

00001

Identifier Type: -

Identifier Source: org_study_id