RCT of aspirin and fish oil for the prevention of thrombosis in arterio-venous fistulae for dialysis access

这项随机、安慰剂对照的临床试验旨在确定抗血小板药物阿司匹林和鱼油单独或联合使用是否能有效降低透析中用于进入循环系统的动静脉瘘（AVF）中早期血栓形成（血凝块）的风险。该试验将由澳大利亚肾脏试验网络（AKTN）进行。将在3年内招募1200例需要血液透析、计划进行AVF创建且目前未服用抗血小板药物的患者。AVF是血液透析患者的公认标准，因为它利用患者自己的动脉和静脉，允许重复进入血管系统，并发症的风险最小。AVF的失败意味着使用下永久静脉导管或动静脉人工移植物。这些装置的插入成本更高，并且由于感染和血栓形成而具有更高的失败风险。通过简单、廉价和容易获得的干预措施降低失败率，有可能减少这些问题。选择阿司匹林是因为它具有公认的抗血栓形成作用。鱼油具有许多生物学效应，使其成为预防血管通路血栓形成的有吸引力的药物。研究治疗为阿司匹林100 mg/天或匹配安慰剂，鱼油4 gm/天或匹配安慰剂，均从手术前一天开始，持续3个月。如果试验证明一种或两种药物的积极作用，这将导致血栓形成减少，更快的时间工作透析通路，并减少手术的需要。

This randomised, placebo-controlled clinical trial aims to determine whether the anti-platelet agents aspirin and fish oil, either alone or in combination, will effectively reduce the risk of early thrombosis (blood clots) in arterio-venous fistulae (AVF) that are used for accessing the circulatory system in dialysis. The trial is to be conducted by the Australasian Kidney Trials Network (AKTN). 1200 patients requiring haemodialysis who are scheduled to undergo creation of an AVF and are not currently taking anti-platelet agents will be recruited over 3 years. AVF is the accepted standard for haemodialysis patients because it utilises the patient's own artery and vein to allow repeated access to the vascular system with a minimal risk of complications. Failure of the AVF means the use of inferior permanent venous catheters or arterio-venous artificial grafts. These devices are more costly to insert, and have an increased risk of failure due to infection and thrombosis. Reducing this rate of failure by simple, cheap and readily available interventions has the potential to reduce these problems. Aspirin has been chosen because of its well-established anti-thrombosis effects. Fish oil has a number of biological effects which make it an attractive agent for the prevention of vascular access thrombosis. Study treatment will be aspirin 100 mg per day or matching placebo, and fish oil 4 gm daily or matching placebo, both commencing on the day prior to surgery and continued for 3 months. If the trial demonstrates a positive effect of either or both agents, this will lead to a reduction in thromboses, quicker time to working dialysis access, and less need for surgery.