Skip to content

Trial Comparing One-stage With Two-stage Basilic Vein Transposition

Randomized Trial Comparing Transposition of the Basilic Vein, for Vascular Access, Performed in One-stage Versus Two-stages

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01274117
Enrollment
16
Registered
2011-01-11
Start date
2010-12-31
Completion date
2014-05-31
Last updated
2017-10-25

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

Conditions

Brachiobasilic Arteriovenous Fistula

Keywords

Chronic renal failure, Basilic vein transposition fistula

Brief summary

Arteriovenous fistulas (AVFs) are made by joining a vein to an artery in order to get the vein dilated with sufficient blood flow in order to puncture the vein and clear the blood from wastes, in patients whose kidneys are destroyed and cannot provide this function. The success rate of this procedure varies between 50-80% and depends mainly on the size of the vein, with success being higher with larger veins. One of the veins used for an AVF is the basilic vein, located at the upper arm. This vein is however deeply located and necessitates movement (transposition) during surgery to a less deep and lateral path before it is joined to the artery, in order to be used. A single study has shown that surgery performed in two parts (one to enlarge the vein and the second one to relocate the enlarged vein under the wound, not in a new path) is more successful than doing the procedure altogether. The aim of this study is to confirm the findings of the single study mentioned above (one versus two stages of basilic vein AVF), with the difference that the vein will be relocated outside the main wound, a method that is widely accepted as being better.

Detailed description

Arteriovenous fistulas (AVFs) are made by anastomosing a vein to an artery in order to get the vein dilated with sufficient blood flow in order to puncture the vein and perform hemodialysis in patients with renal failure. The success rate of this procedure varies between 50-80% and depends mainly on the size of the vein, with success being higher with larger veins. One of the veins used for an AVF is the basilic vein, located at the upper arm. This vein is however deeply located and necessitates transposition during surgery to a less deep and lateral subcutaneous plane before the anastomosis with the artery, in order to be used. A single study has shown that surgery performed in two stages (one to enlarge the vein and the second one to relocate the enlarged vein under the wound, not in a new path) is more successful than doing the procedure in one stage. The aim of this study is to confirm the findings of the single study mentioned above (one versus two stages of basilic vein AVF), with the difference that the basilic vein will be relocated outside the main wound, a method that is widely accepted as being better.

Interventions

PROCEDURETransposition of the basilic vein and anastomosis with the brachial vein

One-stage vs two-stage transposition of the basilic vein

Sponsors

University of Patras
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* chronic renal failure on hemodialysis * chronic renal failure with anticipated hemodialysis

Exclusion criteria

* Patient unwillingness, not consenting * Cephalic vein options * Basilic vein less than 2.5 mm * Basilic vein with intrinsic lesions, unsuitable for use

Design outcomes

Primary

MeasureTime frameDescription
Maturation rate6-10 weeksUsage of the AVF (or clearance in case of pre-hemodialysis)
Long term primary, primary assisted and secondary patency1-3 yearsLong term primary, primary assisted and secondary patency

Secondary

MeasureTime frameDescription
Complication rate1-3 yearsHematoma, steal syndrome, venous hypertension
Basilic vein size4 weeksBasilic vein size on ultrasound

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026