None listed
Conditions
Interventions
Administered at the induction of anaesthesia for carotid endarterectomy, the trial intervention consists of an initial bolus of 20ml of dextran 1 (promit) or normal saline placebo given intravenously followed by intravenous infusion of 10% dextran 40 or normal saline placebo at an infusion rate of 125 ml/hr for 4 hours then 42 ml/hr for a further 12 hours.
Sponsors
National Stroke Research Institute and John Hunter Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Symptomatic or a symptomatic carotid artery atherosclerosis considered suitable for Carotid Endarterectomy (CEA) performed under either general or loco-regional anaesthesia.
Exclusion criteria
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.
Outcome results
None listed