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

NCT03981484 | Unknown Phase 2 DMC

• 1 other identifier: 00001
• Study Type: interventional
• Target: 280
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 24 Hour Mortality

  Assess if patient is alive at 24 hours post treatment

  24 hours after enrollment

Study Arms (2)

PCC

EXPERIMENTAL

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

Biological: Prothrombin Complex Concentrate

Standard of Care

ACTIVE COMPARATOR

standard resuscitation methods only

Biological: Whole Blood, Plasma, Packed Red Blood Cells

Interventions

Prothrombin Complex Concentrate BIOLOGICAL

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

PCC

Whole Blood, Plasma, Packed Red Blood Cells BIOLOGICAL

site's standard resuscitation protocol

Standard of Care

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥15 years old
• anticipate giving 4+ units based on Revised Assessment of Bleeding and Transfusion score ≥ 2

You may not qualify if:

• Cardiopulmonary Resuscitation \> 5 minutes
• Penetrating cranial injury or exposed brain matter
• Anticoagulation treatment
• Transfer patients
• Known pregnancy
• Prisoners

Sponsors & Collaborators

• Bellal A. Joseph, MD, FACS: lead

MeSH Terms

Conditions

Hemostatic Disorders; Hemorrhage

Interventions

Factor IX

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Enzyme Precursors; Enzymes and Coenzymes; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors; Biological Factors

Study Officials

• Bellal Joseph, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Seach, BS

CONTACT

520-626-2876; aseach@surgery.arizona.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of the Division of Trauma, Acute Care, Burn, and Emergency Surgery

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 10, 2019
• Study Start: January 1, 2020
• Primary Completion: October 1, 2022
• Study Completion: January 1, 2023
• Last Updated: June 10, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share