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Fish oil Inhibition of Stenosis in Haemodialysis grafts study

Completed
Conditions
End Stage Renal Disease (ESRD)
Urological and Genital Diseases
Renal disease
Registration Number
ISRCTN15838383
Lead Sponsor
Canadian Institutes of Health Research (CIHR) (Canada)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
232
Inclusion Criteria

1. End stage renal disease haemodialysis patients who require a graft access
2. 18 and above years of age, either sex

Exclusion Criteria

1. Acute renal failure, likely to be reversible with recovery of renal function
2. Surgical revision of a previous access e.g. a jump graft (i.e. must be a new PTFE graft)
3. Pregnancy
4. Active malignancy
5. Active major bleed within one month of enrolment (see below for definition of major bleed)
6. Malignant hypertension
7. Receiving more than two anti-platelet agents or anticoagulants i.e. use of Acetylsalicylic Acid (ASA) and coumadin is not an exclusion
8. Life expectancy less than six months
9. PTFE grafts that fail prior to and including post-operative day seven
10. Involvement in another graft trial
11. Current fish oil ingestion at the time of randomisation
12. Any known allergy to fish or fish products

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The proportion of PTFE grafts with loss of native patency within 12 months
Secondary Outcome Measures
NameTimeMethod
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