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

Not Applicable

Terminated

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

• 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
• Primary Completion: 2023-11-01
• Study Completion: 2023-11-01
• Results First Submitted: 2025-03-07
• Status Verified: 2025-09
• Results First Submitted QC: 2025-09-09
• Last Update Submitted: 2025-09-09
• Results First Posted: 2025-09-11
• Last Update Posted: 2025-09-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Had Successful Use of Arteriovenous Fistula for Dialysis	6 months	Functional clinical patency means the number of participants who were able to use their brachial basilic arteriovenous fistula (BBAVF) successfully for dialysis within 6 months of surgical creation. It refers to using two dialysis needles in at least 75% of dialysis sessions over four weeks without need for additional procedure or surgery, as determined by their providers.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Had Catheter Related Complications	6 months	Number 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
Number of Participants Who Had > 3 Months of Catheter Dependency After Arteriovenous Creation	6 months	Number of participants who had \> 3 months of catheter dependency after arteriovenous fistula creation
Patient-Reported Outcomes Measurement Information System Scores Over 6 Months	6-month	Average quality of life scores assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) for physical function, fatigue, sleep disturbance, and ability to participate in social roles and activities. Data are presented as T-score, which are standardized scores with a mean of 50 and a standard deviation for the reference population (typically the US general population). A T-score of 50 represents the population average. A higher T-score indicates more of the concept being measured and lower T-score indicate less.

Trial Locations

Locations (1)

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