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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Coagulopathy Hemorrhage | Biological: Prothrombin Complex Concentrate Biological: Whole Blood, Plasma, Packed Red Blood Cells | Phase 2 |
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 |
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 |
- 24 Hour Mortality [ Time Frame: 24 hours after enrollment ]Assess if patient is alive at 24 hours post treatment
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 15 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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
Contact: Andrea Seach, BS | 520-626-2876 | aseach@surgery.arizona.edu |
Principal Investigator: | Bellal Joseph, MD | University of Arizona |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hemostatic Disorders Blood Coagulation Disorders Hemorrhage Pathologic Processes Hematologic Diseases Vascular Diseases |
Cardiovascular Diseases Hemorrhagic Disorders Thrombin Hemostatics Coagulants |