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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03981484
Recruitment Status : Unknown
Verified June 2019 by Bellal A. Joseph, MD, FACS, University of Arizona.
Recruitment status was:  Not yet recruiting
First Posted : June 10, 2019
Last Update Posted : June 10, 2019
Sponsor:
Information provided by (Responsible Party):
Bellal A. Joseph, MD, FACS, University of Arizona

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.

Condition or disease Intervention/treatment Phase
Coagulopathy Hemorrhage Biological: Prothrombin Complex Concentrate Biological: Whole Blood, Plasma, Packed Red Blood Cells Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: REPlaCE- Randomized Trial Evaluating the Use of Prothrombin Complex concEntrate to Improve Survival in Patients With Traumatic Coagulopathy
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 24 Hour Mortality [ Time Frame: 24 hours after enrollment ]
    Assess if patient is alive at 24 hours post treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03981484


Contacts
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Contact: Andrea Seach, BS 520-626-2876 aseach@surgery.arizona.edu

Sponsors and Collaborators
Bellal A. Joseph, MD, FACS
Investigators
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Principal Investigator: Bellal Joseph, MD University of Arizona
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Responsible Party: Bellal A. Joseph, MD, FACS, Chief of the Division of Trauma, Acute Care, Burn, and Emergency Surgery, University of Arizona
ClinicalTrials.gov Identifier: NCT03981484    
Other Study ID Numbers: 00001
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemostatic Disorders
Blood Coagulation Disorders
Hemorrhage
Pathologic Processes
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Thrombin
Hemostatics
Coagulants