Dextran in Carotid Endarterectomy Trial
A Multicentre, Randomised, Placebo contolled trial of intravenous 10% Dextran 40 (Rheomacrodex), in the Prevention of Stroke in Carotid Surgery
National Stroke Research Institute and John Hunter Health
1,412 participants
Jan 1, 2002
Interventional
Conditions
Eligibility
Inclusion Criteria1
- Symptomatic or a symptomatic carotid artery atherosclerosis considered suitable for Carotid Endarterectomy (CEA) performed under either general or loco-regional anaesthesia.
Exclusion Criteria8
- 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.
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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.
Locations(1)
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ACTRN12609000673246