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

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 risk will be defined as status greater than 12 months post thromboembolic event.

The inclusion criteria include: (1) Low risk status as defined above, (2) Chronic warfarin therapy of at least 12 months duration with target INR of 2.0-3.0. Patients will be excluded from the study if one or more of the following are met: (1) 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, (2) Pregnant, breastfeeding or planning to become pregnant or breastfeed, (3) inhibitors allergy/sensitivity to dabigatran etexilate, (4)Creatinine Clearance < 30 mls/min, (5) Concomitant treatment with strong P-glycoprotein (6) Known thrombophilia including Factor V Leiden mutation, prothrombin gene mutation, antithrombin deficiency, protein C deficiency, protein S deficiency, and antiphospholipid antibody syndrome, and (7) inability to provide written informed consent.

Research Plan:

Patients will be identified by performing a manual search of the anticoagulation clinic database to identify patients on long-term warfarin therapy (>12 months). The results will be gleaned to identify patients who meet the inclusion criteria listed above.