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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best method to create a brachial basilic arteriovenous fistula (BBAVF), crucial for kidney failure patients on dialysis. It compares a one-stage approach, completed in a single procedure, with a two-stage approach, divided into two separate procedures. The trial aims to determine which method yields better results and improves patients' quality of life. It seeks participants who are on dialysis, need a new access point, and have a suitable vein in their upper arm. As an unphased trial, it offers patients the chance to contribute to significant research that could enhance dialysis treatment options.

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 prior data suggests that these approaches for creating a brachial basilic arteriovenous fistula are safe?

Research has shown that both the one-stage and two-stage methods for creating a brachial basilic arteriovenous fistula (BBAVF) are generally safe. These procedures are standard for patients needing dialysis access.

Studies have found that the one-stage method might maintain the fistula's function better after 12 months compared to the two-stage method, relating to effectiveness rather than safety. Both methods can have wound complications, but no strong evidence indicates one is safer than the other.

The two-stage method might initially succeed better in keeping the fistula open, but it requires two surgeries, again concerning effectiveness, not safety. Over time, both methods perform similarly well.

In summary, both methods are well-tolerated and widely used. Any risks are typical of surgical procedures, and the choice often depends on the patient's specific needs and the surgeon's preference. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the different approaches to creating a brachial-basilic arteriovenous fistula (BBAVF) because these methods could potentially improve outcomes for patients needing vascular access. The one-stage approach is unique because it combines the creation of the arteriovenous connection and the transposition of the vein in a single procedure, potentially reducing recovery time and hospital visits. On the other hand, the two-stage approach allows the fistula to mature before transposing the vein, which might improve the success rate of the fistula. By comparing these two methods, researchers hope to find the most effective and efficient technique for patients.

What evidence suggests that this trial's approaches for creating a brachial basilic arteriovenous fistula could be effective?

This trial will compare two methods for creating a brachial basilic arteriovenous fistula (BBAVF): a one-stage approach and a two-stage approach. Research has shown that each method offers distinct benefits. The one-stage procedure completes everything in a single surgery, and studies found that 49.1% of these cases had the fistula remain open after 12 months. The two-stage method involves two surgeries and might initially maintain the fistula's openness better. However, over time, both methods appear equally effective in keeping the fistula functional. The best approach depends on the patient's specific needs and vein size. ^{2 6 7 8 9}

Who Is on the Research Team?

Tze-Woei Tan, MD

Principal Investigator

Banner University Medical Center Tucson/University of Arizona

Are You a Good Fit for This Trial?

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

Life expectancy ≥ 12 months

My upper arm vein is wider than 3 mm.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. ejves.com ejves.com/article/S1078-5884(24)01384-4/fulltext

Outcomes of Single or Two Stage Brachiobasilic ... This nationwide registry based study compared the complications and long term patency of brachiobasilic arteriovenous fistulae created in one (BB1) or two (BB2 ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0741521418320676

Comparison of one-stage and two-stage upper arm ... Key Findings: Compared with two-stage procedures, single-stage brachiobasilic arteriovenous fistula creation resulted in higher 12-month primary patency (49.1% ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10527688/

Two-Stage Offers No Advantages over Single- ... We found that for veins 3 mm or larger, a 2-stage BBF does not offer an advantage over a single-stage BBF in terms of mortality, patency, dialysis use with the ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6094037/

Transposed Brachial–Basilic Arteriovenous Fistula for ... Data on the features of one- or two-stage procedures of TBBAVF have been accumulated from several retrospective studies. Mixed opinions have been reported ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1743919115001661

A comparison between one-stage and two ... Our data suggests creation of brachiobasilic fistulas using a two-staged procedure may result in improved patency rates.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29937034/

A systematic review and meta-analysis of one-stage versus ... This study suggests potential benefit of a two-stage over a one-stage procedure for brachiobasilic AVF creation.

7. journals.lww.com journals.lww.com/ejos/fulltext/2022/01000/one_stage_versus_two_stage_brachiobasilic.6.aspx

One-stage versus two-stage brachiobasilic arteriovenous... The aim of this study is to compare between one-stage and the two-stage techniques in the formation of BBAVF regarding primary patency, secondary patency, and ...

8. vsijournal.org vsijournal.org/journal/view.html?volume=34&number=3&spage=51&year=2018

A Systematic Review and Meta-Analysis of Randomized ... A comparison of the outcomes of one-stage and two-stage brachiobasilic arteriovenous fistulas. J Vasc Surg. 58, 1300-1304. Pubmed CrossRef. Hossny, A (2003) ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37337468/

Comparison of wound complications between one-stage ... Research assessing the outcome of brachiobasilic arteriovenous fistulas (BB-AVF) after a one- and two-stage technique was conducted.