Health Condition 1: null- Atrial Fibrillation
Conditions
Interventions
Intervention1: Dalteparin: Drug: Dalteparin
5,000 iu or 200 iu/kg depending on the type of surgery injection will be given subcutaneously, once a day for a minimum of 4 days or until the INR is 2.0
Co
Sponsors
Lawson Health Research Institute
Canadian Institutes of Health Research (CIHR)
iProcess Clnical Marketing Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| major thromboembolismTimepoint: 90 days from randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| major bleeding minor bleeding a composite of major bleeding and major thromboembolic events minor thromboembolic events overall survival.Timepoint: 90 days from randomization | — |
Countries
India
Contacts
Public ContactRicha Bhatt
Outcome results
None listed