|- candidate number||5758|
|- NTR Number||NTR1819|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||15-mei-2009|
|- Secondary IDs||2008/43 / NL23188.101.08 METC TWO Rotterdam / ABRv3|
|- Public Title||ELBA TRIAL.|
Vena basilica transpositie versus elleboogsfistel voor hemodialyse.
|- Scientific Title||Ellbow arteriovenousfistulae versus vena basilica transposition as vascular access in hemodialysis patients.|
|- ACRONYM||ELBA trial|
|- hypothesis||In the current elderly population the vena basilica transposition is superior to the brachiocubiti fistula in terms of easy cannulation and maturation. Primary outcome is primary patency after one year.|
|- Healt Condition(s) or Problem(s) studied||Hemodialysis, Renal disease, AV-fistula|
|- 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||1. Locoregional or systemic infection;|
2. Not being able to give informed consent;
3. Ischemia of ipsilateral arm.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||20-mei-2009|
|- planned closingdate||20-mei-2012|
|- Target number of participants||215|
|- Interventions||Vena basilica transposition versus brachiocubiti fistula.|
|- Primary outcome||Is there a difference in primary patency after one year in vena basilica transposition compared with brachiocubiti fistula for chronic hemodialysis.|
|- Secondary outcome||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.
|- Timepoints||Primary patency after one year
effect on peripheral circulation (cardiac output, DBI) after one week, 6 weeks, 6 months, one year.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| ELBA Trial study center|
|- CONTACT for SCIENTIFIC QUERIES||Drs. A. Well, van|
|- Sponsor/Initiator ||Sint Franciscus Gasthuis (SFG) , Academic Hospital Maastricht (azM), Erasmus Medical Center, Rotterdam, Maasstad Hospital|
(Source(s) of Monetary or Material Support)
|Sint Franciscus Gasthuis (SFG), Rotterdam|
|- Brief summary||According to current international standards (NKF K/DOQI guidelines) a brachiocubiti arteriovenous fistula is the second option for creating hemodialysis access in patients with end stage renal disease. The most frequently used elbow fistula are the brachiocephalic, brachiocubiti or gracz fistula. These are relatively easy fistula to create but it is not possible to predict if the fistula will mainly drain in the superficially located cephalic vein or in the deeper located basilic or brachial vein. If the main outflow is to one of the deeper veins the fistula will be difficult or impossible to cannulate. The basilic vein is often of good quality because of its deep location. When using it for a fistula it will need to be transposed to a superficial location to garantee easy cannulation. In the current elderly dialysis population a basilic vein transposition might be a better option for a secondary procedure than an elbow fistula because of the higher chance of maturation and more easy cannulation. Even though it implicates a larger wound area and longer operating time.
The main objective of this study is to show that a basilic vein transposition is superior to the elbow fistula in terms of easy cannulation and maturation. Primary outcome is one year patency. Secondary outcomes are: secondary patency, access usability, effect of access on peripheral and systemic circulation.
|- Main changes (audit trail)|
|- RECORD||15-mei-2009 - 30-sep-2009|