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

Not Applicable

Active, not recruiting

• Conditions: Arterio-venous Fistula; End Stage Renal Failure; Hemodialysis Access Failure
• Interventions: Procedure: One stage approach

• Registration Number: NCT04376567
• Lead Sponsor: Tze-Woei Tan

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.

Study Timeline

• Study First Submitted: 2020-01-15
• Study First Submitted QC: 2020-05-01
• Study First Posted: 2020-05-06
• Study Start: 2021-10-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-10
• Last Update Posted: 2024-06-11
• Primary Completion: 2025-10-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
One stage approach	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.
Two Stage approach	One 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.

Primary Outcome Measures

Name	Time	Method
Numbers of participants who had successful use of arteriovenous fistula for dialysis	6 months	Functional clinical patency: Numbers of participant who had successful use of brachial basilic arteriovenous fistula (BBAVF) in 75% of dialysis sessions over four weeks without need for additional procedure or surgery.

Secondary Outcome Measures

Name	Time	Method
Duration of catheter dependency for dialysis after arteriovenous fistula creation in day	12 months	Average duration of catheter dependency after BBAVF creation in participants who required dialysis
Numbers of participants who had catheter related complications	12 months	Numbers of participants with dialysis catheter related complications, including infection, procedure to exchange catheter due to malfunction.; outcomes of Primary Clinical Functional Patency or CVC-related bacteremia or death
Patient reported quality of life	6-month and 12-month	Average ratings of quality of life among participants using the Patient-Reported Outcomes Measurement Information System in physical health, physical functioning, general mental health, emotional distress, satisfaction with social activities and relationships.

Trial Locations

Locations (1)

Banner University Medical Center Tucson; 🇺🇸 Tucson, Arizona, United States