Brachiobasilic Arteriovenous Fistula Clinical Trial
Official title:
Randomized Trial Comparing Transposition of the Basilic Vein, for Vascular Access, Performed in One-stage Versus Two-stages
| Verified date | October 2017 |
| Source | University of Patras |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 16 |
| Est. completion date | May 2014 |
| Est. primary completion date | May 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 90 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Greece | University Hospital of Patras | Patras | Achaia |
| Lead Sponsor | Collaborator |
|---|---|
| University of Patras |
Greece,
El Mallah S. Staged basilic vein transposition for dialysis angioaccess. Int Angiol. 1998 Jun;17(2):65-8. — View Citation
Kakkos SK, Tsolakis IA, Papadoulas SI, Lampropoulos GC, Papachristou EE, Christeas NC, Goumenos D, Lazarides MK. Randomized controlled trial comparing primary and staged basilic vein transposition. Front Surg. 2015 Apr 29;2:14. doi: 10.3389/fsurg.2015.000 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Maturation rate | Usage of the AVF (or clearance in case of pre-hemodialysis) | 6-10 weeks | |
| Primary | Long term primary, primary assisted and secondary patency | Long term primary, primary assisted and secondary patency | 1-3 years | |
| Secondary | Complication rate | Hematoma, steal syndrome, venous hypertension | 1-3 years | |
| Secondary | Basilic vein size | Basilic vein size on ultrasound | 4 weeks |