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N/A

One-Stage vs Two-Stage Approach for Arteriovenous Fistula

N/A

Waitlist Available

Led By Tze-Woei Tan, MD

Research Sponsored by Tze-Woei Tan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Greater than 3 mm diameter of upper arm basilic vein on venous duplex scan

ESRD receiving hemodialysis (CVC) in need for new hemodialysis access

Must not have

Brachial artery stenosis or occlusion

Current immunosuppressive medication, chemotherapy or radiation therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-month and 12-month

Awards & highlights

No Placebo-Only Group

Summary

This study is evaluating whether a new surgical approach for creating a new arteriovenous fistula may improve outcomes for patients receiving renal replacement therapy.

Who is the study for?

This trial is for adults over 18 with end-stage renal disease (ESRD) on hemodialysis needing a new dialysis access, who have a suitable vein size and are expected to live at least another year. It's not for those with brachial artery issues, blood clotting disorders, short life expectancy, or those pregnant, breastfeeding, or on immune-suppressing treatments.

What is being tested?

The study compares two standard methods of creating a brachial basilic arteriovenous fistula (BBAVF) for dialysis in kidney failure patients: the one-stage procedure versus the two-stage procedure. Patients will be randomly assigned to either method to evaluate outcomes and quality of life.

What are the potential side effects?

While specific side effects are not listed here as it involves surgical procedures rather than drug interventions, potential risks may include bleeding, infection at the surgery site, narrowing of the vessels used for the fistula (stenosis), or clotting within the fistula.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My upper arm vein is wider than 3 mm.

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I have end-stage renal disease and need a new way to receive my dialysis.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a blockage or narrowing in my arm's main artery.

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I am not on immunosuppressive drugs, chemotherapy, or radiation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-month and 12-month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-month and 12-month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-month and 12-month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Numbers of participants who had successful use of arteriovenous fistula for dialysis

Secondary study objectives

Duration of catheter dependency for dialysis after arteriovenous fistula creation in day

Numbers of participants who had catheter related complications

Patient reported quality of life

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: One stage approachActive Control1 Intervention

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.

Group II: Two Stage approachActive Control1 Intervention

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.

0 / 5Eligibility criteria met