Status:
WITHDRAWN
Validation of a Novel Dabigatran Based Peri-Operative Bridging Anticoagulation Protocol for Patients on Chronic Warfarin Therapy
Lead Sponsor:
Nova Scotia Health Authority
Conditions:
Venous Thromboses
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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? ...
Detailed Description
Subject Selection: The study population will include low risk patients on long-term warfarin therapy for venous thromboembolic disease (VTE) followed by the hematology anticoagulation clinic. Low ris...
Eligibility Criteria
Inclusion
- Low risk status VTE
- Chronic warfarin therapy of at least 12 months duration with target INR of 2.0-3.0
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01810237
Start Date
March 1 2013
End Date
September 1 2013
Last Update
January 31 2017
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