Venous Thromboses Clinical Trial
Official title:
Validation of a Novel Dabigatran Based Peri-Operative Bridging Anticoagulation Protocol for Patients on Chronic Warfarin Therapy
Verified date | January 2017 |
Source | Nova Scotia Health Authority |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Research Questions:
1. Does using dabigatran bridging result in consistent therapeutic anticoagulation? What
percentage of patients will become subtherapeutic on warfarin once dabigatran is
stopped?
2. What is the incidence of bleeding events with the use of dabigatran overlapped with
warfarin for bridging?
3. What is the cost benefit of using dabigatran instead of dalteparin for bridging
anticoagulation?
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 2013 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Low risk status VTE - Chronic warfarin therapy of at least 12 months duration with target INR of 2.0-3.0 Exclusion Criteria: - Increased risk of bleeding: bleeding requiring transfusion in last 12 months, history of hemorrhagic stroke or intracranial hemorrhage, recent gastrointestinal bleeding {<6 months}, history of a bleeding disorder - Pregnant, breastfeeding or planning to become pregnant or breastfeed - Inhibitors allergy/sensitivity to dabigatran etexilate - Creatinine Clearance < 30 mls/min - Concomitant treatment with strong P-glycoprotein - Known thrombophilia including Factor V Leiden mutation, prothrombin gene mutation, antithrombin deficiency, protein C deficiency, protein S deficiency, and antiphospholipid antibody syndrome - Inability to provide written informed consent |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Nova Scotia Health Authority |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Validation of a novel Dabigatran Based Peri-Operative Bridging Anticoagulation Protocol for Patients on Chronic Warfarin Therapy | 1 Year. |
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