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

Australasian Kidney Trials Network0 个研究点目标入组 657 人开始时间: 2007年11月5日最近更新: 2021年6月14日

适应症

试验速览

暂无简介。

•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

发起方

Australasian Kidney Trials Network