Status:
COMPLETED
Effectiveness of Bridging Anticoagulation for Surgery (The BRIDGE Study)
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Arterial Thromboembolic Events
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Blood thinners, such as warfarin, prevent blood clots from forming, thereby reducing the risk of a stroke or heart attack. When people undergo surgery or certain procedures, they must stop using warfa...
Detailed Description
Approximately 2 million people in North America take the anticoagulant warfarin to prevent stroke, heart attack, and other events related to blood clots. Warfarin needs to be stopped before a person u...
Eligibility Criteria
Inclusion
- Receiving warfarin therapy for at least 3 months, administered to achieve an international normalized ratio (INR) range of 2.0 to 3.0
- Requiring temporary interruption of warfarin for pre-specified elective procedure or surgery
- Presence of one of the following conditions:
- Chronic (permanent or paroxysmal) nonvalvular atrial fibrillation, confirmed by at least one prior electrocardiography recording or pacemaker or acid citrate dextrose (ACD) interrogation
- Chronic (permanent or paroxysmal) valvular atrial fibrillation with evidence of mitral valvular heart disease, confirmed by the same criteria as nonvalvular atrial fibrillation
- Presence of at least one of the following major stroke risk factors:
- Older than 75 years of age
- Hypertension
- Diabetes mellitus
- Congestive heart failure or left ventricular dysfunction
- Previous ischemic stroke, systemic embolism, or transient ischemic attack (TIA)
Exclusion
- Any mechanical prosthetic heart valve
- Stroke (ischemic or hemorrhagic), systemic embolism, or TIA within the past 12 weeks
- Venous thromboembolism (deep vein thrombosis and/or pulmonary embolism) within past 12 weeks
- Major bleeding within the past 6 weeks
- Severe renal insufficiency, measured through a calculated creatinine clearance of less than 30 mL/min
- Thrombocytopenia
- Life expectancy less than 1 month
- Condition that impairs compliance with trial protocol, such as cognitive impairment, an uncontrolled psychiatric condition, or geographic inaccessibility
- Pregnancy
- Allergy to heparin or history of heparin-induced thrombocytopenia
- Having one of the following surgeries or procedures during warfarin interruption:
- Cardiac surgery, such as coronary artery bypass or heart valve replacement
- Neurosurgery that is intracranial or intraspinal, such as tumor resection or aneurysm repair
- High-risk non-surgical procedures, such as brain biopsy
- Other surgical or non-surgical procedure that, at the discretion of the surgeon, precludes administration of therapeutic-dose low molecular weight heparin (LMWH) at any time in the post-procedure period
- More than one surgery planned during the trial period
- Prior participation in this trial
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
1884 Patients enrolled
Trial Details
Trial ID
NCT00786474
Start Date
July 1 2009
End Date
February 1 2015
Last Update
March 7 2016
Active Locations (1)
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1
Duke Clinical Research Institute
Durham, North Carolina, United States, 27715