None listed
Conditions
Brief 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.
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 (part
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
Sponsors
Australasian Kidney Trials Network
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1.Stage 4 or 5 chronic kidney disease 2.Currently on haemodialysis or haemodialysis is planned to start within 6 months (including patients currently on peritoneal dialysis). 3.Planned AVF will be the primary haemodialysis access mechanism. 4.Surgery to create an arterio-venous fistula in the upper or lower arm is planned. 5.Treating team agreeable to patient’s involvement in the trial 6.Informed consent
Exclusion criteria
1.Revision of existing AVF rather than de novo AVF 2.Medical indication for anti-platelet or thrombolytic agents other than aspirin 3.Known intolerance of agents including hypersensitivity to aspirin, allergy to any other NSAIDs or fish 4.Current use of omega-3 fatty acids within 4 weeks of commencing trial. 5.Pregnancy, lactation or intention to fall pregnant during the time course of the study 6.Known bleeding disorder or established diagnosis of active or suspected bleeding 7.History of GI ulcers or bleeding within the last 3 months 8.Platelet count less than 100 x 109 /L 9.Known active peptic ulcer disease 10.Severe hepatic insufficiency 11.Already receiving anti-coagulation therapy such as warfarin 12.Receiving regular non-steroidal anti-inflammatory (NSAIDS) agents for another indication such as arthritis 13.Syndrome of asthma, rhinitis and nasal polyps if uncontrolled on usual therapy 14.Plan to have other (non-access) surgery within 2 weeks of trial medication period 15.Potential non-compliance with treatment regimen in the view of the treating clinicians 16.Involved in another clinical trial where the intervention being trialled is likely to confound the outcome of this trial 17.Previously randomised to this trial
Outcome results
None listed