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

June 7, 2019 updated by: Bellal A. Joseph, MD, FACS
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

280

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PCC
single dose of 4-Factor PCC in addition to standard resuscitation methods
Biological: Prothrombin Complex Concentrate
single dose of 25 IU/kg of 4-PCC at time of enrollment
ACTIVE_COMPARATOR: Standard of Care
standard resuscitation methods only
Biological: Whole Blood, Plasma, Packed Red Blood Cells
site's standard resuscitation protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24 Hour Mortality
Time Frame: 24 hours after enrollment
Assess if patient is alive at 24 hours post treatment
24 hours after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bellal A. Joseph, MD, FACS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 1, 2020

Primary Completion (ANTICIPATED)

October 1, 2022

Study Completion (ANTICIPATED)

January 1, 2023

Study Registration Dates

First Submitted

June 6, 2019

First Submitted That Met QC Criteria

June 7, 2019

First Posted (ACTUAL)

June 10, 2019

Study Record Updates

Last Update Posted (ACTUAL)

June 10, 2019

Last Update Submitted That Met QC Criteria

June 7, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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