A Safety and Effectiveness Study of LMWH Bridging Therapy Versus Placebo Bridging Therapy for Patients on Long Term Warfarin and Require Temporary Interruption of Their Warfari
- Conditions
- Health Condition 1: null- Atrial Fibrillation
- Registration Number
- CTRI/2010/091/000017
- Lead Sponsor
- awson Health Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1773
Informed consent,
Patients aged >18 with prosthetic heart valves receiving long-term oral anticoagulation with warfarin, or
Patients with atrial fibrillation and a major risk factor (previous TIA or stroke, high blood pressure, diabetes, aged >75, moderate/severe left ventricle dysfunction), who require elective non-cardiac surgery or an invasive procedure with reversal of their anticoagulant therapy.
Evidence of active bleeding within last 30 days prior to stopping warfarin.
Platelet count <100 x 109/L.
Spinal or neurosurgery.
Life expectancy less than 3 months.
Calculated creatinine clearance <30 ml/min
Patients requiring cardiac surgery.
Multiple prosthetic valves or Starr-Edwards valves or prosthetic valves with a history of stroke or TIA
History of heparin induced thrombocytopenia (HIT)
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method major thromboembolismTimepoint: 90 days from randomization
- Secondary Outcome Measures
Name Time Method major bleeding <br>minor bleeding <br>a composite of major bleeding and major thromboembolic events <br>minor thromboembolic events <br>overall survival.Timepoint: 90 days from randomization