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

Understanding the Patient-Centered Outcomes for One-stage and Two-stage Brachial Basilic Upper Extremity Arteriovenous Fistulas: A Pilot Trial

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.

Study Overview

• Status: Terminated
• Conditions: Hemodialysis Access Failure; End Stage Renal Failure; Arterio-venous Fistula
• Intervention / Treatment: Procedure: One stage approach

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 Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • Banner University Medical Center Tucson

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: One stage approach; Upper extremity brachial basilic arteriovenous fistula will be created either using one stage or two stage approach.; Other Names: Two stage approach
Active Comparator: 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.	Procedure: One stage approach; Upper extremity brachial basilic arteriovenous fistula will be created either using one stage or two stage approach.; Other Names: Two stage approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Had Successful Use of Arteriovenous Fistula for Dialysis	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Had Catheter Related Complications	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	6 months
Number of Participants Who Had > 3 Months of Catheter Dependency After Arteriovenous Creation	Number of participants who had > 3 months of catheter dependency after arteriovenous fistula creation	6 months
Patient-Reported Outcomes Measurement Information System Scores Over 6 Months	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.	6-month

Collaborators and Investigators

• Sponsor: Tze-Woei Tan
• Collaborators: University of Utah; Rancho Los Amigos National Rehabilitation Center
• Investigators: Principal Investigator: Tze-Woei Tan, MD, Banner University Medical Center Tucson/University of Arizona

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): November 1, 2023
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: January 15, 2020
• First Submitted That Met QC Criteria: May 1, 2020
• First Posted (Actual): May 6, 2020

Study Record Updates

• Last Update Posted (Estimated): September 11, 2025
• Last Update Submitted That Met QC Criteria: September 9, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Renal failure; Upper extremity arteriovenous fistula; Brachial basilic arteriovenous fistula
• Additional Relevant MeSH Terms: Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Male Urogenital Diseases; Pathological Conditions, Anatomical; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Congenital Abnormalities; Cardiovascular Abnormalities; Vascular Malformations; Fistula; Arteriovenous Malformations; Vascular Fistula; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Renal Insufficiency, Chronic; Arteriovenous Fistula
• Other Study ID Numbers: 0702

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No