CompletedPhase 3Phase 4ACTRN12607000569404

A placebo-controlled trial to assess the effect of aspirin and fish oil (omega-3 fatty acids) in the prevention of early thrombosis in arterio-venous fistulae in patients with chronic kidney disease requiring haemodialysis

A randomised, double-blind, placebo-controlled, factorial-design trial to assess the effect of aspirin and fish oil (omega-3 fatty acids) in the prevention of early thrombosis in arterio-venous fistulae in patients with Stage IV or V chronic kidney disease requiring haemodialysis

Sponsor

Australasian Kidney Trials Network

Enrollment

950 participants

Start Date

Aug 21, 2008

Study Type

Interventional

Conditions

Early thrombosis in arterio-venous fistulae in patients with Stage IV or V chronic kidney disease requiring haemodialysis

Summary

FAVOURED is a multicentre, randomised controlled trial design. The objectives of this trial are to determine whether the use of the omega-3 fatty acids and to a lesser extent, aspirin, will effectively improve postsurgical outcomes for patients with de novo arterio-venous fistulae (AVF). The study population are patients with stage IV or V chronic kidney disease who require or will require haemodialysis and who are scheduled to undergo creation of an AVF. The primary outcome is AVF Access Failure, which is a composite of Thrombosis, AVF Abandonment, and Cannulation Failure during the Cannulation Assessment Period. Secondary outcomes include AVF access failure according to strata of aspirin use, safety and adverse events of omega-3 fatty acids and aspirin alone or in combination, catheter use, and rescue interventions.

Eligibility

Sex: Both males and femalesMin Age: 19 Yearss

Plain Language Summary

Simplified for easier understanding

This study is about a placebo-controlled trial to assess the effect of aspirin and fish oil (omega-3 fatty acids) in the prevention of early thrombosis in arterio-venous fistulae in patients with chronic kidney disease requiring haemodialysis. It is looking for adults aged 19 and older to participate. To join, participants should meet requirements such as: 1.Stage 4 or 5 chronic kidney disease. Participants will be guided through the study procedures by the research team and may need to attend scheduled visits.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The study medication used is 4g Omega 3 fatty acid (4 1g capsules per day (46% eicosapentaenoic acid (EPA) and 38% docosapentaenoic acid (DHA)) and 100mg aspirin (1 100mg tablet per day). Participants can randomised to 6 arms; 1. Omega 3 fatty acid and aspirin, 2. Omega 3 fatty acid and aspirin placebo, 3. Omega 3 fatty acid placebo and aspirin, 4. Omega 3 fatty acid placebo and aspirin placebo, 5. Omega 3 fatty acid (participants already taking aspirin) 6. Omega 3 fatty acid placebo (participants already taking aspirin) Participants start the study medication 24 hours prior to AVF surgery and contiune to 12 Week visit