Outcomes for One-stage and Two-stage Brachial Basilic Arteriovenous Fistulas

NCT ID: NCT04376567

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2023-11-01

Brief Summary

An arteriovenous (AV) fistula is essential for patients with kidney failure on dialysis. There is no clear data on the best method to create a new brachial basilic AV fistula (BBAVF), so the choice between a single procedure and two separate procedures is left to the surgeon. Both approaches are standard care. This study aims to compare patient-centered outcomes and quality of life by randomly assigning patients needing a BBAVF to either a one-stage or two-stage procedure.

Detailed Description

The aim of the pilot trial is to compare the outcomes of patients with end stage kidney failure (ESKD) who are candidates for a new brachial basilic arteriovenous fistula (BBAVF). Patients will be randomized to either one-stage or two-stage BBAVF procedure, both standard of care for creating BBAVF. The main outcome will be primary clinical functional patency, defined as successful use of BBAVF over a continuous 4-week period without any need for additional procedure on the BBAVF. The secondary outcomes are fistula-related complications, duration of central venous catheter (CVC) for those on dialysis, and quality of life (QoL) measures. The study hypothesizes that the primary patency will be superior following the two-stage BBAVF procedure compare to one-stage procedure. However, CVC-related complications are expected to be higher following the two-stage procedure compared to the one-stage procedure. Patient will be followed for a minimum duration of 12-months per subject.

Conditions

End Stage Renal Failure; Hemodialysis Access Failure; Arterio-venous Fistula

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

One stage approach

To create a brachial-basilic arteriovenous fistula (BBAVF) using a one-stage approach. The arteriovenous anastomosis is performed and the basilic vein is transposed during the same procedure.

Group Type: ACTIVE_COMPARATOR

One stage approach

Intervention Type: PROCEDURE

Upper extremity brachial basilic arteriovenous fistula will be created either using one stage or two stage approach.

Two Stage approach

To create a BBAVF using a two-stage approach, the arteriovenous anastomosis is performed during the first procedure. The superficialization or transposition of the fistula is then performed 6 to 8 weeks later, after the fistula has matured.

Group Type: ACTIVE_COMPARATOR

One stage approach

Intervention Type: PROCEDURE

Upper extremity brachial basilic arteriovenous fistula will be created either using one stage or two stage approach.

Interventions

One stage approach

Upper extremity brachial basilic arteriovenous fistula will be created either using one stage or two stage approach.

Intervention Type: PROCEDURE

Other Intervention Names

Two stage approach

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years;

2. ESRD receiving hemodialysis in need for new hemodialysis access;

3. Candidate for one-stage and two-stage BVT procedure as judged by the enrolling investigator;

4. Greater than 3 mm diameter of upper arm basilic vein on venous duplex scan;

5. Life expectancy ≥ 12 months;

Exclusion Criteria

1. Life expectancy < 12 months;

2. Brachial artery stenosis or occlusion;

3. A documented hypercoagulable state (defined as a known blood disorder associated with venous or arterial thrombosis);

4. Current immunosuppressive medication, chemotherapy or radiation therapy;

5. Pregnancy or lactation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: collaborator

Rancho Los Amigos National Rehabilitation Center

OTHER

Sponsor Role: collaborator

Tze-Woei Tan

OTHER

Sponsor Role: lead

Responsible Party

Tze-Woei Tan

Clinical Associate Professor of Surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Tze-Woei Tan, MD

Role: PRINCIPAL_INVESTIGATOR

Banner University Medical Center Tucson/University of Arizona

Locations

Banner University Medical Center Tucson

Tucson, Arizona, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

0702

Identifier Type: -

Identifier Source: org_study_id