Validation of a Novel Dabigatran Based Peri-Operative Bridging Anticoagulation Protocol for Patients on Chronic Warfarin Therapy
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ClinicalTrials.gov Identifier: NCT01810237 |
Recruitment Status :
Withdrawn
(No patients recruited)
First Posted : March 13, 2013
Last Update Posted : January 31, 2017
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Sponsor:
Nova Scotia Health Authority
Information provided by (Responsible Party):
Sudeep Shivakumar, Nova Scotia Health Authority
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Brief Summary:
Research Questions:
- Does using dabigatran bridging result in consistent therapeutic anticoagulation? What percentage of patients will become subtherapeutic on warfarin once dabigatran is stopped?
- What is the incidence of bleeding events with the use of dabigatran overlapped with warfarin for bridging?
- What is the cost benefit of using dabigatran instead of dalteparin for bridging anticoagulation?
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Venous Thromboses | Drug: Dabigatran. | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Validation of a Novel Dabigatran Based Peri-Operative Bridging Anticoagulation Protocol for Patients on Chronic Warfarin Therapy |
Study Start Date : | March 2013 |
Actual Primary Completion Date : | July 2013 |
Actual Study Completion Date : | September 2013 |
Resource links provided by the National Library of Medicine

MedlinePlus related topics:
Blood Thinners
Arm | Intervention/treatment |
---|---|
Experimental: Dabigtran instead of LMWH for perioperative bridging. |
Drug: Dabigatran.
Dabigatran will be used instead of LMWH for anticoagulation bridging. |
Primary Outcome Measures :
- Validation of a novel Dabigatran Based Peri-Operative Bridging Anticoagulation Protocol for Patients on Chronic Warfarin Therapy [ Time Frame: 1 Year. ]
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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
No Contacts or Locations Provided
Responsible Party: | Sudeep Shivakumar, MD FRCPC, Nova Scotia Health Authority |
ClinicalTrials.gov Identifier: | NCT01810237 |
Other Study ID Numbers: |
SS001 |
First Posted: | March 13, 2013 Key Record Dates |
Last Update Posted: | January 31, 2017 |
Last Verified: | January 2017 |
Additional relevant MeSH terms:
Thrombosis Venous Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Dabigatran |
Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anticoagulants |