FAVOURED (Fish oil and Aspirin in Vascular access OUtcomes in REnal Disease)

• Conditions: Prevention of early thrombosis in arterio-venous fistulae in patients with Stage IV or V chronic kidney disease requiring haemodialysis; MedDRA version: 14.0Level: LLTClassification code 10059336Term: Haemodialysis fistula thrombosisSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; MedDRA version: 14.0Level: LLTClassification code 10060478Term: Thrombosis prophylaxis in haemodialysisSystem Organ Class: 10042613 - Surgical and medical procedures

• Registration Number: EUCTR2009-014868-19-GB
• Lead Sponsor: Australian Kidney Trials Network, University of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 954

Inclusion Criteria

Patients must meet the following inclusion criteria:
1.Stage 4 or 5 Chronic Kidney Disease
2.Currently on haemodialysis or haemodialysis is planned to start within 12 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.Aged over 19 years
6.Treating team agreeable to patient’s involvement in the trial
7.Informed consent

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

Exclusion Criteria

Patients must not meet any of the following exclusion criteria:
1.Revision of existing AVF rather than de novo AVF
2.Medical indication for anti-platelet or thrombolytic agents*
3.Known intolerance of agents including hypersensitivity to aspirin, allergy to any other NSAIDs or fish or hypersensitivity to soya.
4.Current use of aspirin within two weeks of commencing trial, or 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 where, in the opinion of the investigator, aspirin or omega-3 fatty acids would be contraindicated for the planned procedure.
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.
*Note: Patients who fail to meet the exclusion criteria 2 (Medical indication for anti-platelet or thrombolytic agents) and exclusion criteria 4 (Current use of aspirin within two weeks of commencing trial), and who are otherwise suitable will be enrolled into the expanded protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified