Background: The FAVOURED study is an international multicentre, double-blind, placebo-controlled trial which\ncommenced recruitment in 2008 and examines whether omega-3 polyunsaturated fatty acids (omega-3 PUFAs)\neither alone or in combination with aspirin will effectively reduce primary access failure of de novo arteriovenous\nfistulae (AVF) in patients with stage 4 and 5 chronic kidney disease. Publication of new evidence derived from\nadditional studies of clopidogrel and a high screen failure rate due to prevalent aspirin usage prompted an updated trial\ndesign.\nMethods/design: The original trial protocol published in 2009 has undergone two major amendments, which were\nimplemented in 2011. Firstly, the primary outcome ââ?¬Ë?early thrombosisââ?¬â?¢ at 3 months following AVF creation was broadened\nto a more clinically relevant outcome of ââ?¬Ë?AVF access failureââ?¬â?¢; a composite of thrombosis, AVF abandonment and\ncannulation failure at 12 months. Secondly, participants unable to cease using aspirin were allowed to be enrolled and\nrandomised to omega-3 PUFAs or placebo. The revised primary aim of the FAVOURED study is to test the hypothesis that\nomega-3 PUFAs will reduce rates of AVF access failure within 12 months following AVF surgery. The secondary aims are\nto examine the effect of omega-3 PUFAs and aspirin on the individual components of the primary end-point, to examine\nthe safety of study interventions and assess central venous catheter requirement as a result of access failure.\nDiscussion: This multicentre international clinical trial was amended to address the clinically relevant question of whether\nthe usability of de novo AVF at 12 months can be improved by the early use of omega-3 PUFAs and to a lesser\nextent aspirin. This study protocol amendment was made in response to a large trial demonstrating that clopidogrel is\neffective in safely preventing primary AVF thrombosis, but ineffective at increasing functional patency. Secondly,\nincluding patients taking aspirin will enrol a more representative cohort of haemodialysis patients, who are significantly\nolder with a higher prevalence of cardiovascular disease and diabetes which may increase event rates and the power of\nthe study.
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