Post-operative low molecular weight heparin bridging therapy versus placebo bridging therapy for patients who are at high risk for arterial thromboembolism
- Conditions
- Arterial thromboembolismCirculatory SystemArterial embolism and thrombosis
- Registration Number
- ISRCTN26119679
- Lead Sponsor
- ondon Health Sciences Centre (Canada)
- Brief Summary
2018 results in: https://ash.confex.com/ash/2018/webprogram/Paper109964.html (added 19/02/2019)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1773
1. Informed consent
2. Patients of either sex, 18 years and older, with prosthetic heart valves receiving long-term oral anticoagulation with warfarin, or
3. Patients with atrial fibrillation and a major risk factor (previous transient ischaemic attack (TIA) or stroke, high blood pressure, diabetes, 75 years and older, moderate/severe left ventricle dysfunction), who require elective non-cardiac surgery or an invasive procedure with reversal of their anticoagulant therapy
1. Evidence of active bleeding prior to stopping warfarin
2. Platelet count less than 100 x 10^9/L
3. Spinal or neurosurgery
4. Life expectancy less than three months
5. Serum creatinine greater than 150 umol/L
6. Patients requiring cardiac surgery
7. Multiple prosthetic valves or Starr-Edwards valves or prosthetic valves with a history of stroke or TIA
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Major thromboembolism including:<br> 1. Ischaemic stroke<br> 2. Symptomatic myocardial infarction<br> 3. Peripheral embolism<br> 4. Valve thrombosis<br> 5. Venous thromboembolism<br> 6. Vascular death<br><br> Outcomes will be measured at three months.<br>
- Secondary Outcome Measures
Name Time Method <br> 1. Minor thromboembolism<br> 2. Major bleeding<br> 3. Minor bleeding<br> 4. Overall survival<br><br> Outcomes will be measured at three months.<br>