One-Stage vs Two-Stage Approach for Arteriovenous Fistula

Overseen By Vianey c Hernandez

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tze-Woei Tan

Must not be taking: Immunosuppressants, Chemotherapy

Disqualifiers: Brachial artery stenosis, Hypercoagulable state, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on immunosuppressive medication, chemotherapy, or radiation therapy.

What data supports the effectiveness of the treatment Brachial Basilic Arteriovenous Fistula?

Research shows that both one-stage and two-stage approaches for creating brachiobasilic arteriovenous fistulas have similar long-term success rates, but the one-stage procedure may lead to faster readiness for use and higher initial success rates. ^{1 2 3 4 5}

Is the brachial basilic arteriovenous fistula generally safe for humans?

The brachial basilic arteriovenous fistula (BBAVF) is generally considered safe, with studies showing low complication rates such as minor swelling and bleeding. Most complications can be managed with timely intervention, and the procedure has a good success rate in terms of maintaining open blood flow. ^{1 2 3 6 7}

How does the brachial basilic arteriovenous fistula treatment differ from other treatments for creating dialysis access?

The brachial basilic arteriovenous fistula can be created in either a one-stage or two-stage procedure, with the one-stage approach offering shorter maturation time and similar long-term success compared to the two-stage method. This treatment is unique because it involves transposing the basilic vein to improve blood flow for dialysis, and the choice between one or two stages depends on specific patient needs and surgical preferences. ^{1 2 4 5 8}

What is the purpose of this trial?

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

Research Team

Tze-Woei Tan, MD

Principal Investigator

Banner University Medical Center Tucson/University of Arizona

Eligibility Criteria

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.

Inclusion Criteria

Anticipated ability to comply with study procedures

My upper arm vein is wider than 3 mm.

Life expectancy ≥ 12 months

Exclusion Criteria

Your doctor expects you to live for less than a year.

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

You are pregnant or breastfeeding.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either a one-stage or two-stage brachial basilic arteriovenous fistula (BBAVF) procedure

6-8 weeks

Multiple visits for surgical procedures and follow-up

Follow-up

Participants are monitored for primary clinical functional patency and quality of life outcomes

12 months

Regular follow-up visits

Treatment Details

Interventions

• Brachial Basilic Arteriovenous Fistula

Trial Overview 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.

Participant Groups

Group I: One stage approach Active Control 1 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 approach Active Control 1 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.

Who Is Running the Clinical Trial?

Tze-Woei Tan

Lead Sponsor

Trials

1

Recruited

60+

University of Southern California

Collaborator

Trials

956

Recruited

1,609,000+

Rancho Los Amigos National Rehabilitation Center

Collaborator

Trials

10

Recruited

2,000+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

Boston University

Collaborator

Trials

494

Recruited

9,998,000+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Two-Stage Offers No Advantages over Single-Stage Arteriovenous Creation: An Analysis of Multicenter National Data. [2023]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

A Systematic Review and Meta-Analysis of Randomized Trials Comparing Two-Stage with One-Stage Brachio-Basilic Vein Fistulas. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of one-stage versus two-stage brachiobasilic arteriovenous fistula creation. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Is the Two-Stage Construction Approach Better for Maturation and Long-term Patency of the Transposed Brachiobasilic Arteriovenous Fistulas? [2023]

5. United States pubmed.ncbi.nlm.nih.gov

A comparison between one- and two-stage brachiobasilic arteriovenous fistulas. [2012]

6. United States pubmed.ncbi.nlm.nih.gov

Outcomes of Transposition of Brachiobasilic Arteriovenous Fistula in Two-Stage Technique: A Single-Centre Experience With Literature Review. [2020]

7. England pubmed.ncbi.nlm.nih.gov

The brachial artery-basilic vein arterio-venous fistula in vascular access for haemodialysis--a review paper. [2005]

8. United States pubmed.ncbi.nlm.nih.gov

A comparison of the outcomes of one-stage and two-stage brachiobasilic arteriovenous fistulas. [2022]