Preventing AVF thrombosis: The rationale and design of the Omega-3 fatty acids (Fish Oils) and Aspirin in Vascular access OUtcomes in REnal Disease (FAVOURED) study

Irish, Ashley, Dogra, Gursharan, Mori, Trevor, Beller, Elaine, Heritier, Stephane, Hawley, Carmel, Kerr, Peter, Robertson, Amanda, Rosman, Johan, Paul-Brent, Peta-Anne, Starfield, Melissa, Polkinghorne, Kevan and Cass, Alan (2009) Preventing AVF thrombosis: The rationale and design of the Omega-3 fatty acids (Fish Oils) and Aspirin in Vascular access OUtcomes in REnal Disease (FAVOURED) study. BMC Nephrology, 10 1: 1-12. doi:10.1186/1471-2369-10-1


Author Irish, Ashley
Dogra, Gursharan
Mori, Trevor
Beller, Elaine
Heritier, Stephane
Hawley, Carmel
Kerr, Peter
Robertson, Amanda
Rosman, Johan
Paul-Brent, Peta-Anne
Starfield, Melissa
Polkinghorne, Kevan
Cass, Alan
Title Preventing AVF thrombosis: The rationale and design of the Omega-3 fatty acids (Fish Oils) and Aspirin in Vascular access OUtcomes in REnal Disease (FAVOURED) study
Journal name BMC Nephrology   Check publisher's open access policy
ISSN 1471-2369
Publication date 2009-01
Sub-type Article (original research)
DOI 10.1186/1471-2369-10-1
Open Access Status DOI
Volume 10
Issue 1
Start page 1
End page 12
Total pages 12
Editor Norton, M.
Place of publication London, United Kingdom
Publisher BioMed Central
Collection year 2010
Language eng
Subject C1
970111 Expanding Knowledge in the Medical and Health Sciences
110312 Nephrology and Urology
Formatted abstract
Background:  Haemodialysis (HD) is critically dependent on the availability of adequate access to the systemic circulation, ideally via a native arteriovenous fistula (AVF). The Primary failure rate of an AVF ranges between 20–54%, due to thrombosis or failure of maturation. There remains limited evidence for the use of anti-platelet agents and uncertainty as to choice of agent(s) for the prevention of AVF thrombosis. We present the study protocol for a randomised, double-blind, placebo-controlled, clinical trial examining whether the use of the anti-platelet agents, aspirin and omega-3 fatty acids, either alone or in combination, will effectively reduce the risk of early thrombosis in de novo AVF.
Methods/Design:
The study population is adult patients with stage IV or V chronic kidney disease (CKD) currently on HD or where HD is planned to start within 6 months in whom a planned upper or lower arm AVF is to be the primary HD access. Using a factorial-design trial, patients will be randomised to aspirin or matching placebo, and also to omega-3 fatty acids or matching placebo, resulting in four treatment groups (aspirin placebo/omega-3 fatty acid placebo, aspirin/omega-3 fatty acid placebo, aspirin placebo/omega-3 fatty acid, aspirin/omega-3 fatty acid). Randomisation will be achieved using a dynamic balancing method over the two stratification factors of study site and upper versus lower arm AVF. The medication will be commenced pre-operatively and continued for 3 months post surgery. The primary outcome is patency of the AVF at three months after randomisation. Secondary outcome measures will include functional patency at six and twelve months, primary patency time, secondary (assisted) patency time, and adverse events, particularly bleeding. Discussion: This multicentre Australian and New Zealand study has been designed to determine whether the outcome of surgery to create de novo AVF can be improved by the use of aspirin and/or omega-3 fatty acids. Recently a placebo-controlled trial has shown that clopidogrel is effective in safely preventing primary AVF thrombosis, but ineffective at increasing functional patency. Our study presents significant differences in the anti-platelet agents used, the study design, and surgical and patient demographics that should contribute further evidence regarding the efficacy of anti-platelet agents.
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ
Additional Notes "Study Protocol". Trial Registration: Australia & New Zealand Clinical Trials Register (ACTRN12607000569404).

 
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Created: Tue, 13 Apr 2010, 10:22:05 EST by Maree Knight on behalf of Medicine - Princess Alexandra Hospital