EUCTR2009-014868-19-GB进行中（未招募）不适用
A randomised, double-blind, placebo-controlled, factorial-design trial to assess the effect of aspirin & fish oil in the prevention of early thrombosis in arterio-venous fistulae in patients with Stage IV/ V chronic renal disease requiring haemodialysis - Favoured Study (Version 9.2 UK)
Australian Kidney Trials Network, University of Queensland0 个研究点目标入组 954 人开始时间: 2011年8月23日最近更新:
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相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 954
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
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