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ELBA Trial Ellbow arteriovenous fistula versus Basilic Vein transposition for chronic hemodialysis.

ELBA Trial Ellbow arteriovenous fistula versus Basilic Vein transposition for chronic hemodialysis. - ELBA Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON33941
Enrollment
215
Registered
2009-01-12
Start date
2009-06-01
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

renal insufficiency and hemodialysis access

Interventions

Creation of an arteriovenous fistula for hemodialysis The intervention will either be Basilic vein transposition or creation of an ellbow arteriovenous fistula.

Sponsors

Sint Franciscus Gasthuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: -active locoregional or systemic infection -ischemia of ipsilateral arm -not being able to understand and/or give informed consent

Design outcomes

Primary

MeasureTime frame
primary study parameters: 1. is there a difference in primary patency after one year?

Secondary

MeasureTime frame
Secundary study parameters: 1. is there a difference in thrombosis-free interval? 2. is there a difference in the amount of interventions needed? 3. Is there a difference in usability ? a. duration untill first cannulation b. total time of non-usability as a result of revision operations c. easy cannulation d. time of compression for hemostasis after cannulation e. complications: infection, thrombosis, aneurysm, haematoma, steal, edema 4. effect of fistula on periferal circulation

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)