ELBA Trial Ellbow arteriovenous fistula versus Basilic Vein transposition for chronic hemodialysis.
Recruiting
- Conditions
- renal insufficiency and hemodialysis access100291491000318410047066
- Registration Number
- NL-OMON33941
- Lead Sponsor
- Sint Franciscus Gasthuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 215
Inclusion Criteria
-end stage renal failure with need for chronic intermittent hemodialysis
-creation of a forerarm fistula is not feasible, or failure of a forearm graft or fistula.
-diameter of brachial artery, cephalic and basilic upper-arm vein of at least 3.0 mm
Exclusion Criteria
-active locoregional or systemic infection
-ischemia of ipsilateral arm
-not being able to understand and/or give informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>primary study parameters:<br /><br><br /><br>1. is there a difference in primary patency after one year?</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secundary study parameters:<br /><br><br /><br>1. is there a difference in thrombosis-free interval?<br /><br>2. is there a difference in the amount of interventions needed?<br /><br>3. Is there a difference in usability ?<br /><br>a. duration untill first cannulation<br /><br>b. total time of non-usability as a result of revision operations<br /><br>c. easy cannulation<br /><br>d. time of compression for hemostasis after cannulation<br /><br>e. complications: infection, thrombosis, aneurysm, haematoma, steal, edema<br /><br>4. effect of fistula on periferal circulation</p><br>