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

Primary Purpose

Brachiobasilic Arteriovenous Fistula

Status
Terminated
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Transposition of the basilic vein and anastomosis with the brachial vein
Sponsored by
University of Patras
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brachiobasilic Arteriovenous Fistula focused on measuring Chronic renal failure, Basilic vein transposition fistula

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of Patras

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

One-stage transposition of the basilic vein

Two-stage transposition of the basilic vein

Arm Description

One-stage transposition of the basilic vein

Two-stage transposition of the basilic vein

Outcomes

Primary Outcome Measures

Maturation rate
Usage of the AVF (or clearance in case of pre-hemodialysis)
Long term primary, primary assisted and secondary patency
Long term primary, primary assisted and secondary patency

Secondary Outcome Measures

Complication rate
Hematoma, steal syndrome, venous hypertension
Basilic vein size
Basilic vein size on ultrasound

Full Information

First Posted
January 10, 2011
Last Updated
October 24, 2017
Sponsor
University of Patras
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1. Study Identification

Unique Protocol Identification Number
NCT01274117
Brief Title
Trial Comparing One-stage With Two-stage Basilic Vein Transposition
Official Title
Randomized Trial Comparing Transposition of the Basilic Vein, for Vascular Access, Performed in One-stage Versus Two-stages
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
PRIMARY EFFICACY OUTCOME MEASURE (MATURATION) WAS SIGNIFICANT, IN FAVOR OF THE TW0-STAGE PROCEDURE
Study Start Date
December 2010 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Patras

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brachiobasilic Arteriovenous Fistula
Keywords
Chronic renal failure, Basilic vein transposition fistula

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
One-stage transposition of the basilic vein
Arm Type
Placebo Comparator
Arm Description
One-stage transposition of the basilic vein
Arm Title
Two-stage transposition of the basilic vein
Arm Type
Experimental
Arm Description
Two-stage transposition of the basilic vein
Intervention Type
Procedure
Intervention Name(s)
Transposition of the basilic vein and anastomosis with the brachial vein
Intervention Description
One-stage vs two-stage transposition of the basilic vein
Primary Outcome Measure Information:
Title
Maturation rate
Description
Usage of the AVF (or clearance in case of pre-hemodialysis)
Time Frame
6-10 weeks
Title
Long term primary, primary assisted and secondary patency
Description
Long term primary, primary assisted and secondary patency
Time Frame
1-3 years
Secondary Outcome Measure Information:
Title
Complication rate
Description
Hematoma, steal syndrome, venous hypertension
Time Frame
1-3 years
Title
Basilic vein size
Description
Basilic vein size on ultrasound
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stavros Kakkos, MD, PhD
Organizational Affiliation
University of Patras
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Patras
City
Patras
State/Province
Achaia
ZIP/Postal Code
265034
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
9754891
Citation
El Mallah S. Staged basilic vein transposition for dialysis angioaccess. Int Angiol. 1998 Jun;17(2):65-8.
Results Reference
background
PubMed Identifier
25973421
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.2015.00014. eCollection 2015.
Results Reference
result
PubMed Identifier
35493925
Citation
Wang J, Gong X, Chen H, Zhong W, Chen Y, Zhou Y, Zhang W, He Y, Lou M. Causative Classification of Ischemic Stroke by the Machine Learning Algorithm Random Forests. Front Aging Neurosci. 2022 Apr 15;14:788637. doi: 10.3389/fnagi.2022.788637. eCollection 2022.
Results Reference
derived
PubMed Identifier
31920571
Citation
Kaneko F, Shindo K, Yoneta M, Okawada M, Akaboshi K, Liu M. A Case Series Clinical Trial of a Novel Approach Using Augmented Reality That Inspires Self-body Cognition in Patients With Stroke: Effects on Motor Function and Resting-State Brain Functional Connectivity. Front Syst Neurosci. 2019 Dec 17;13:76. doi: 10.3389/fnsys.2019.00076. eCollection 2019.
Results Reference
derived
PubMed Identifier
30687164
Citation
Battaglia G, Alesi M, Tabacchi G, Palma A, Bellafiore M. The Development of Motor and Pre-literacy Skills by a Physical Education Program in Preschool Children: A Non-randomized Pilot Trial. Front Psychol. 2019 Jan 9;9:2694. doi: 10.3389/fpsyg.2018.02694. eCollection 2018.
Results Reference
derived

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

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