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

Bellal A. Joseph, MD, FACS

Status and phase: Unknown; Phase 2

Conditions: Hemorrhage; Coagulopathy

Treatments: Biological: Prothrombin Complex Concentrate; Biological: Whole Blood, Plasma, Packed Red Blood Cells

Study type: Interventional

Funder types: Other

Identifiers

NCT03981484

00001

Details and patient eligibility

About

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.

Enrollment: 280 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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280 participants in 2 patient groups

PCC

Experimental group

Description:

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

Treatment:

Biological: Prothrombin Complex Concentrate

Standard of Care

Active Comparator group

Description:

standard resuscitation methods only

Treatment:

Biological: Whole Blood, Plasma, Packed Red Blood Cells