Skip to main page content
Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
, 10, 1

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

Affiliations
Randomized Controlled Trial

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

Ashley Irish et al. BMC Nephrol.

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.

Trial registration: Australia & New Zealand Clinical Trials Register (ACTRN12607000569404).

Figures

Figure 1
Figure 1
Schema for the FAVOURED Trial.

Similar articles

See all similar articles

Cited by 10 PubMed Central articles

See all "Cited by" articles

References

    1. Allon M, Robbin ML. Increasing arteriovenous fistulas in hemodialysis patients: Problems and solutions. Kidney Int. 2002;62(4):1109–1124. doi: 10.1111/j.1523-1755.2002.kid551.x. - DOI - PubMed
    1. Polkinghorne KR, McDonald SP, Atkins RC, Kerr PG. Vascular access and all-cause mortality: a propensity score analysis. J Am Soc Nephrol. 2004;15(2):477–486. doi: 10.1097/01.ASN.0000109668.05157.05. - DOI - PubMed
    1. Pastan S, Soucie JM, McClellan WM. Vascular access and increased risk of death among hemodialysis patients. Kidney Int. 2002;62(2):620–626. doi: 10.1046/j.1523-1755.2002.00460.x. - DOI - PubMed
    1. Excell L, Marshall M, McDonald SP. ANZDATA Registry Report 2004. Adelaide: Australia and New Zealand Dialysis and Transplant Registry; 2004. Haemodialysis; pp. 35–52.
    1. Manns B, Tonelli M, Yilmaz S, Lee H, Laupland K, Klarenbach S, Radkevich V, Murphy B. Establishment and maintenance of vascular access in incident hemodialysis patients: a prospective cost analysis. J Am Soc Nephrol. 2005;16(1):201–209. doi: 10.1681/ASN.2004050355. - DOI - PubMed

Publication types

MeSH terms

Feedback