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

Tze-Woei Tan

Status: Terminated

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

Treatments: Procedure: One stage approach

Study type: Interventional

Funder types: Other

Identifiers

NCT04376567

0702

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

One stage approach

Active Comparator group

Description:

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.

Treatment:

Procedure: One stage approach

Two Stage approach

Active Comparator group

Description:

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.

Treatment:

Procedure: One stage approach