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

Primary Purpose

Coagulopathy, Hemorrhage

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Prothrombin Complex Concentrate
Whole Blood, Plasma, Packed Red Blood Cells
Sponsored by
Bellal A. Joseph, MD, FACS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coagulopathy

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    PCC

    Standard of Care

    Arm Description

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

    standard resuscitation methods only

    Outcomes

    Primary Outcome Measures

    24 Hour Mortality
    Assess if patient is alive at 24 hours post treatment

    Secondary Outcome Measures

    Full Information

    First Posted
    June 6, 2019
    Last Updated
    June 7, 2019
    Sponsor
    Bellal A. Joseph, MD, FACS
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03981484
    Brief Title
    REPlaCE- Randomized Trial Evaluating the Use of Prothrombin Complex concEntrate to Improve Survival in Patients With Traumatic Coagulopathy
    Acronym
    REPLaCE
    Official Title
    REPlaCE- Randomized Trial Evaluating the Use of Prothrombin Complex concEntrate to Improve Survival in Patients With Traumatic Coagulopathy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2020 (Anticipated)
    Primary Completion Date
    October 2022 (Anticipated)
    Study Completion Date
    January 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Bellal A. Joseph, MD, FACS

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coagulopathy, Hemorrhage

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    280 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PCC
    Arm Type
    Experimental
    Arm Description
    single dose of 4-Factor PCC in addition to standard resuscitation methods
    Arm Title
    Standard of Care
    Arm Type
    Active Comparator
    Arm Description
    standard resuscitation methods only
    Intervention Type
    Biological
    Intervention Name(s)
    Prothrombin Complex Concentrate
    Intervention Description
    single dose of 25 IU/kg of 4-PCC at time of enrollment
    Intervention Type
    Biological
    Intervention Name(s)
    Whole Blood, Plasma, Packed Red Blood Cells
    Intervention Description
    site's standard resuscitation protocol
    Primary Outcome Measure Information:
    Title
    24 Hour Mortality
    Description
    Assess if patient is alive at 24 hours post treatment
    Time Frame
    24 hours after enrollment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ≥15 years old anticipate giving 4+ units based on Revised Assessment of Bleeding and Transfusion score ≥ 2 Exclusion Criteria: Cardiopulmonary Resuscitation > 5 minutes Penetrating cranial injury or exposed brain matter Anticoagulation treatment Transfer patients Known pregnancy Prisoners
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Andrea Seach, BS
    Phone
    520-626-2876
    Email
    aseach@surgery.arizona.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bellal Joseph, MD
    Organizational Affiliation
    University of Arizona
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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