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出境医 / 临床实验 / REPlaCE- Randomized Trial Evaluating the Use of Prothrombin Complex concEntrate to Improve Survival in Patients With Traumatic Coagulopathy (REPLaCE)

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

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.

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

Study Design
Layout table for study information
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
Arms and Interventions
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
Outcome Measures
Primary Outcome Measures :
  1. 24 Hour Mortality [ Time Frame: 24 hours after enrollment ]
    Assess if patient is alive at 24 hours post treatment


Eligibility Criteria
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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
Contacts and Locations

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
Layout table for investigator information
Principal Investigator: Bellal Joseph, MD University of Arizona
Tracking Information
First Submitted Date  ICMJE June 6, 2019
First Posted Date  ICMJE June 10, 2019
Last Update Posted Date June 10, 2019
Estimated Study Start Date  ICMJE January 2020
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2019) 		24 Hour Mortality [ Time Frame: 24 hours after enrollment ]
Assess if patient is alive at 24 hours post treatment
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE REPlaCE- Randomized Trial Evaluating the Use of Prothrombin Complex concEntrate to Improve Survival in Patients With Traumatic Coagulopathy
Official Title  ICMJE REPlaCE- Randomized Trial Evaluating the Use of Prothrombin Complex concEntrate to Improve Survival in Patients With Traumatic Coagulopathy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Coagulopathy
  • Hemorrhage
Intervention  ICMJE
  • Biological: Prothrombin Complex Concentrate
    single dose of 25 IU/kg of 4-PCC at time of enrollment
  • Biological: Whole Blood, Plasma, Packed Red Blood Cells
    site's standard resuscitation protocol
Study Arms  ICMJE
  • Experimental: PCC
    single dose of 4-Factor PCC in addition to standard resuscitation methods
    Intervention: Biological: Prothrombin Complex Concentrate
  • Active Comparator: Standard of Care
    standard resuscitation methods only
    Intervention: Biological: Whole Blood, Plasma, Packed Red Blood Cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 7, 2019) 		280
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2023
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Andrea Seach, BS 520-626-2876 aseach@surgery.arizona.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03981484
Other Study ID Numbers  ICMJE 00001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Bellal A. Joseph, MD, FACS, University of Arizona
Study Sponsor  ICMJE Bellal A. Joseph, MD, FACS
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bellal Joseph, MD University of Arizona
PRS Account University of Arizona
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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