Validation of a Novel Dabigatran Based Peri-Operative Bridging Anticoagulation Protocol for Patients on Chronic Warfarin Therapy

• Status: Withdrawn
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

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?

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?

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nova Scotia Health Authority
• Treatments: Dabigatran; Warfarin

Criteria

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