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

Study Overview
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Brief Summary
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The absence of reliable data to establish the optimal surgical approach for creating a new Brachial Basilic Arteriovenous Fistula (BBAVF) has resulted in high degree of treatment equipoise and the decision to use one-stage or two-stage approach is largely based on surgeon's preference. The pilot trial will provide a framework for an evidence-based surgical approach to create a BBAVF for patients receiving renal replacement therapy. The pragmatic trial design will allow the inclusion of different surgical techniques currently used by the access surgeons to create a new BBAVF. Subjects in whom randomly assigned approach (one-stage or two-stage) is not completed will be considered appropriately treated as intended to account for the risk of primary fistula failure. The investigator will use the patient-centric clinical endpoints and patient reported outcomes (PROs) to incorporate the perspective of patients undergoing complex The goal is to prospectively evaluate the impact of the one-stage and two-stage BBAVF approaches on qualitative quality of life (QOL) in order to address the knowledge gap within the existing literature on complex arterovenous fistula (AVF) procedures. The investigator will use the NIH-sponsored Patient-Reported Outcome Measurement Information System (PROMIS) Computerized Adaptive Testing (CAT) tool to evaluate self-reported measures for functions, symptoms, behaviors, and feelings following the BBAVF procedure

Detailed Description
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Primary Aim: To compare the primary endpoint event rates in patients with ESRD and candidates for a new BBAVF randomized to have one-stage or two-stage BBAVF procedure. Primary Endpoint: Primary Clinical Functional Patency, defined as the successful use of the index BBAVF with two needles for 75% of dialysis sessions over a continuous 4-week period without any endovascular or surgical procedure on the fistula (modified from the HFM study).Time to first occurrence of a qualifying clinical event will be compared utilizing follow-up at 6-month and 12-month after fistula creation (minimum of 12-month/subject). Secondary Aims: To compare the secondary endpoints (Fistula-related, CVC-related, and composite clinicaloutcomes) of subjects randomizing to one-stage or two-stage BBAVF procedure. CVC-related events will be calculated from the index procedure in the one-stage approach and the first procedure for the two-stage BBAVF approach. Secondary Endpoints: 1) Fistula-related outcome: stenosis and thrombosis, infection, arm swelling, hand ischemia, surgery or intervention, and hospitalization; 2) CVC-related outcome: duration of dependency, infection, bacteremia, and additional CVC procedure (exchange, placement of new CVC); and 3) Composite outcomes of Primary Clinical Functional Patency or CVC-related bacteremia or death. Hypothesis: Primary Clinical Functional Patency will be superior following two-stage compared to one-stage BBAVF procedure. CVC-related complications will be higher following two-stage compared to one-stage BBAVf procedure the investigator will recruit 60 subjects aged 18 years or older with ESRD who will undergo a BBAVF. Thirty subjects will be randomized in the one-stage approach and 30 subjects in the two-stage approach. The expectation for enrollment is 1 subject/month/site, and the recruitment period will be for 12 months. Inclusion criteria (all must be present for inclusion): 1. Age ≥ 18 years; 2. ESRD receiving hemodialysis (CVC) 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; 6. Anticipated ability to comply with study procedures; Exclusion criteria (none of these can be met for inclusion): 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

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

Conditions
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End Stage Renal Failure

Intervention / Treatment
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* Other: randomization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years; ESRD receiving hemodialysis (CVC) 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; Anticipated ability to comply with study procedures 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 -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: One stage BBAVF<br>comparison | Other: randomization<br>* subjects scheduled to have a BBAVF will be randomized to either the One-stage or the Two stage BBAVF<br>|
| Active Comparator: Two Stage BBAVF<br>comparison | Other: randomization<br>* subjects scheduled to have a BBAVF will be randomized to either the One-stage or the Two stage BBAVF<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Functional Patency | successful use of the index BBAVF with two needles for >75% of dialysis sessions over a continuous 4-week period without any endovascular or surgical procedure on the fistula. Time to first occurrence of a qualifying clinical event will be compared utilizing follow-up at 6-month and 12-month after fistula creation | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fistula related outcomes | physical outcomes outcomes of Primary Clinical Functional Patency or CVC-related bacteremia or death | one year | 
| patient reported outcomes | patient reported outcomes using PROMIS CAT testing | compared over 1 year |