Abstract
Background: The FAVOURED study is an international multicentre, double-blind, placebo-controlled trial which commenced recruitment in 2008 and examines whether omega-3 polyunsaturated fatty acids (omega-3 PUFAs) either alone or in combination with aspirin will effectively reduce primary access failure of de novo arteriovenous fistulae (AVF) in patients with stage 4 and 5 chronic kidney disease. Publication of new evidence derived from additional studies of clopidogrel and a high screen failure rate due to prevalent aspirin usage prompted an updated trial design.
Methods/design: The original trial protocol published in 2009 has undergone
two major amendments, which were implemented in 2011. Firstly, the primary
outcome 'early thrombosis' at 3 months following AVF creation was broadened to
a more clinically relevant outcome of 'AVF access failure'; a composite of
thrombosis, AVF abandonment and cannulation failure at 12 months. Secondly,
participants unable to cease using aspirin were allowed to be enrolled and
randomised to omega-3 PUFAs or placebo. The revised primary aim of the FAVOURED
study is to test the hypothesis that omega-3 PUFAs will reduce rates of AVF
access failure within 12 months following AVF surgery. The secondary aims are
to examine the effect of omega-3 PUFAs and aspirin on the individual components
of the primary end-point, to examine the safety of study interventions and
assess central venous catheter requirement as a result of access failure.
Discussion: This multicentre international clinical trial was amended to
address the clinically relevant question of whether the usability of de novo
AVF at 12 months can be improved by the early use of omega-3 PUFAs and to a
lesser extent aspirin. This study protocol amendment was made in response to a
large trial demonstrating that clopidogrel is effective in safely preventing
primary AVF thrombosis, but ineffective at increasing functional patency.
Secondly, including patients taking aspirin will enrol a more representative
cohort of haemodialysis patients, who are significantly older with a higher
prevalence of cardiovascular disease and diabetes which may increase event
rates and the power of the study.
Original language | English |
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Article number | 89 |
Pages (from-to) | 1-8 |
Number of pages | 8 |
Journal | BMC Nephrology |
Volume | 16 |
DOIs |
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Publication status | Published - 27 Jun 2015 |