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

• ClinicalTrials.gov Identifier: NCT03981484
• Recruitment Status: Unknown
• First Posted: June 10, 2019
• Last Update Posted: June 10, 2019
• Sponsor: Bellal A. Joseph, MD, FACS
• Information provided by (Responsible Party): Bellal A. Joseph, MD, FACS, University of Arizona

Tracking Information

• First Submitted Date: June 6, 2019
• First Posted Date: June 10, 2019
• Last Update Posted Date: June 10, 2019
• Estimated Study Start Date: January 2020
• Estimated Primary Completion Date: October 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: REPlaCE- Randomized Trial Evaluating the Use of Prothrombin Complex concEntrate to Improve Survival in Patients With Traumatic Coagulopathy
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment

Condition

• Coagulopathy
• Hemorrhage

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: June 7, 2019): 280
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 2023
• Estimated Primary Completion Date: October 2022 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 15 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03981484
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Bellal A. Joseph, MD, FACS, University of Arizona
• Original Responsible Party: Same as current
• Current Study Sponsor: Bellal A. Joseph, MD, FACS
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Bellal Joseph, MD; University of Arizona

• PRS Account: University of Arizona
• Verification Date: June 2019