Dextran in Carotid Endarterectomy Trial
- Conditions
- Carotid Endarterectomy and ThromboembolismStroke - Ischaemic
- Registration Number
- ACTRN12609000673246
- Lead Sponsor
- ational Stroke Research Institute and John Hunter Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1412
Symptomatic or a symptomatic carotid artery atherosclerosis considered suitable for Carotid Endarterectomy (CEA) performed under either general or loco-regional anaesthesia.
Documented history of congestive cardiac failure New York Heart Association Functional Classification equal to or greater than 3 (NYHA=/>GD 3), unstable angina or acute myocardial infarction within 3 months of surgery.
Renal impairment as measured by a serum creatinine of greater than 0.20 mmol/l.
Thrombocytopaenia of less than 100,000/mm3.
Previous hypersensitivity to dextrans.
Concomitant ipsilateral balloon and/or stenting procedure with CEA.
Patients remaining on warfarin during surgery and those who will receive concomitant heparin therapy post-operatively are also excluded. Patients who are treated with warfarin (without heparin) may be included if the International Normalised Ratio (INR) on the day of surgery is below 1.5.
Lack of informed consent.
Combined CEA/Coronary Artery Bypass Grafts (CABGs) procedure.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ipsilateral fatal and non-fatal stroke, hemispheric or retinal[At 30 days post-intervention];Ipsilateral Transient Ischaemic Attack (TIA)[At 30 days post-intervention]
- Secondary Outcome Measures
Name Time Method Any non-fatal or fatal stroke[At 30 days post-intervention];Death due to any cause[At 30 days post-intervention];Unstable angina or non-fatal myocardial infarction[At 30 days post-intervention]