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ELBA TRIAL. Vena basilica transpositie versus elleboogsfistel voor hemodialyse.

Ellbow arteriovenousfistulae versus vena basilica transposition as vascular access in hemodialysis patients.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25309
Enrollment
215
Registered
2009-05-15
Start date
2009-05-20
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

hemodialysis, end stage renal disease (ESRD), fistula, patency, steal, thrombosis dialyse, nierfalen, av-fistel,

Interventions

Vena basilica transposition versus brachiocubiti fistula.

Sponsors

Dr AC vd Ham, vascular surgeon Sint Franciscus Gasthuis Rotterdam Dr JHM Tordoir, vascular surgeon Ac ziekenhuis Maastricht Dr AAEAde Smet, vascular surgeon Maastadziekenhuis Rotterdam Dr MPFM Vrancken Peeters, vascular surgeon Erasmus Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Failing fore-arm fistula; 2. No options for fore-arm fistula ( venous and arterial diameter < 2 mm ); 3. Mean diameter of vena basilica and vena cephalica and arteria brachialis of 3 or more mm.

Exclusion criteria

Exclusion criteria: 1. Locoregional or systemic infection; 2. Not being able to give informed consent; 3. Ischemia of ipsilateral arm.

Design outcomes

Secondary

MeasureTime frame
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, related to: duration untill first cannulation, total time of non-usability as a result of revision operations, easy cannulation, hemostasis after cannulation, hematoma, infection, steal, aneurysm, oedema; 4. Effect of the fistula on peripheral circulation.

Primary

MeasureTime frame
Is there a difference in primary patency after one year in vena basilica transposition compared with brachiocubiti fistula for chronic hemodialysis.

Contacts

Public ContactELBA Trial study center

Sint Franciscus Gasthuis, secretary surgery department, Postbus 10900

+31 (0)10 4616289

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)