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

This study has been terminated.
(PRIMARY EFFICACY OUTCOME MEASURE (MATURATION) WAS SIGNIFICANT, IN FAVOR OF THE TW0-STAGE PROCEDURE)
Sponsor:
Information provided by (Responsible Party):
Stavros Kakkos, University of Patras
ClinicalTrials.gov Identifier:
NCT01274117
First received: January 10, 2011
Last updated: December 1, 2014
Last verified: December 2014
History of Changes
  Purpose

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.


Condition Intervention
Brachiobasilic Arteriovenous Fistula
 Procedure: Transposition of the basilic vein and anastomosis with the brachial vein

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Trial Comparing Transposition of the Basilic Vein, for Vascular Access, Performed in One-stage Versus Two-stages

Resource links provided by NLM:

MedlinePlus related topics: Fistulas
U.S. FDA Resources

Further study details as provided by University of Patras:

Primary Outcome Measures:
  • Maturation rate [ Time Frame: 6-10 weeks ] [ Designated as safety issue: No ]
    Usage of the AVF (or clearance in case of pre-hemodialysis)

  • Long term primary, primary assisted and secondary patency [ Time Frame: 1-3 years ] [ Designated as safety issue: No ]
    Long term primary, primary assisted and secondary patency


Secondary Outcome Measures:
  • Complication rate [ Time Frame: 1-3 years ] [ Designated as safety issue: Yes ]
    Hematoma, steal syndrome, venous hypertension

  • Basilic vein size [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Basilic vein size on ultrasound
Enrollment: 16
Study Start Date: December 2010
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: One-stage transposition of the basilic vein
One-stage transposition of the basilic vein
 Procedure: Transposition of the basilic vein and anastomosis with the brachial vein
One-stage vs two-stage transposition of the basilic vein
Experimental: Two-stage transposition of the basilic vein
Two-stage transposition of the basilic vein
 Procedure: Transposition of the basilic vein and anastomosis with the brachial vein
One-stage vs two-stage transposition of the basilic vein

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.

  Eligibility
Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01274117

Locations
Greece
University Hospital of Patras
Patras, Achaia, Greece, 265034
Sponsors and Collaborators
University of Patras
Investigators
Principal Investigator: Stavros Kakkos, MD, PhD University of Patras
  More Information

Publications:

Responsible Party: Stavros Kakkos, Assistant Professor, University of Patras
ClinicalTrials.gov Identifier: NCT01274117     History of Changes
Other Study ID Numbers: 2/20-4-10
Study First Received: January 10, 2011
Last Updated: December 1, 2014
Health Authority: Greece: Ethics Committee

Keywords provided by University of Patras:
Chronic renal failure
Basilic vein transposition fistula

Additional relevant MeSH terms:
Arteriovenous Fistula
Arteriovenous Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
 Fistula
Pathological Conditions, Anatomical
Vascular Diseases
Vascular Fistula
Vascular Malformations

ClinicalTrials.gov processed this record on March 03, 2015