TerminatedNot Applicable

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

Stopped: The PI is leaving the institution and the trial will be not resuming.

United States2 participantsStarted 2021-10-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age ≥ 18 years;
✓. ESRD receiving hemodialysis in need for new hemodialysis access;
✓. Candidate for one-stage and two-stage BVT procedure as judged by the enrolling investigator;
✓. Greater than 3 mm diameter of upper arm basilic vein on venous duplex scan;
✓. Life expectancy ≥ 12 months;

Exclusion criteria

✕. Life expectancy \< 12 months;
✕. Brachial artery stenosis or occlusion;
✕. A documented hypercoagulable state (defined as a known blood disorder associated with venous or arterial thrombosis);
✕. Current immunosuppressive medication, chemotherapy or radiation therapy;
✕. Pregnancy or lactation

What they're measuring

Number of Participants Who Had Successful Use of Arteriovenous Fistula for Dialysis

Timeframe: 6 months

Trial details

NCT IDNCT04376567

SponsorTze-Woei Tan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-01

Results submitted2025-03-07

View on ClinicalTrials.gov More End Stage Renal Failure trials