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
- Conditions
- Early thrombosis in arterio-venous fistulae in patients with Stage IV or V chronic kidney disease requiring haemodialysisRenal and Urogenital - Kidney disease
- Registration Number
- ACTRN12607000569404
- Lead Sponsor
- Australasian Kidney Trials Network
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 657
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AVF Access Failure which is a composite of Thrombosis (absence of a thrill or bruit clinically and/or the requirement of Rescue Intervention), AVF Abandonment (permanent abandonment of study AVF) and Cannulation Failure (failure to successfully cannulate the study AVF in 8 or more of the 12 HD sessions during the Cannulation Assessment Period).<br>Cannulation Assessment Period (CAP) is based on when the patient commences maintenance haemodialysis (HD); If the participant starts HD prior to Week 12, the CAP starts from the first HD session after Week 12, if the partticipant start HD after Week 12, the CAP start at the first HD session.[Between Surgery and Month 12]
- Secondary Outcome Measures
Name Time Method