RecruitingPhase 2ACTRN12609000673246

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


Sponsor

National Stroke Research Institute and John Hunter Health

Enrollment

1,412 participants

Start Date

Jan 1, 2002

Study Type

Interventional

Conditions


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether a drug called Dextran (given through a drip into the vein during and after surgery) can reduce the risk of stroke during a procedure called carotid endarterectomy. Carotid endarterectomy is an operation to remove a build-up of fat (plaque) from the artery in the neck that supplies blood to the brain. Small clots can sometimes form during or after this surgery and cause a stroke. Dextran is a fluid that may help prevent clots from forming. The trial compares patients who receive Dextran to those who do not, to see if it reduces the risk of stroke or other complications. You may be eligible if: - You are 18 years of age or older - You have carotid artery narrowing (symptomatic or asymptomatic) that requires a carotid endarterectomy - Your surgery will be performed under general or local/regional anaesthesia You may NOT be eligible if: - You have severe heart failure (NYHA Class 3 or higher), unstable angina, or a recent heart attack within 3 months - You have significant kidney problems (creatinine above 0.20 mmol/L) - Your platelet count is below 100,000/mm³ - You have had a previous allergic reaction to dextrans - You are on warfarin during surgery (unless INR is below 1.5) - You require simultaneous coronary artery bypass grafting Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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)

Australia

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ACTRN12609000673246