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The PI is leaving the institution and the trial will be not resuming.
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| Name | Class |
|---|---|
| University of Utah | OTHER |
| Rancho Los Amigos National Rehabilitation Center | OTHER |
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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.
The aim of the pilot trial is to compare the outcomes of patients with end stage kidney failure (ESKD) who are candidates for a new brachial basilic arteriovenous fistula (BBAVF). Patients will be randomized to either one-stage or two-stage BBAVF procedure, both standard of care for creating BBAVF. The main outcome will be primary clinical functional patency, defined as successful use of BBAVF over a continuous 4-week period without any need for additional procedure on the BBAVF. The secondary outcomes are fistula-related complications, duration of central venous catheter (CVC) for those on dialysis, and quality of life (QoL) measures. The study hypothesizes that the primary patency will be superior following the two-stage BBAVF procedure compare to one-stage procedure. However, CVC-related complications are expected to be higher following the two-stage procedure compared to the one-stage procedure. Patient will be followed for a minimum duration of 12-months per subject.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One stage approach | Active Comparator | 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. |
|
| Two Stage approach | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| One stage approach | Procedure | Upper extremity brachial basilic arteriovenous fistula will be created either using one stage or two stage approach. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Had Successful Use of Arteriovenous Fistula for Dialysis | Functional clinical patency means the number of participants who were able to use their brachial basilic arteriovenous fistula (BBAVF) successfully for dialysis within 6 months of surgical creation. It refers to using two dialysis needles in at least 75% of dialysis sessions over four weeks without need for additional procedure or surgery, as determined by their providers. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Had Catheter Related Complications | Number of participants with dialysis catheter related complications, including infection, procedure to exchange catheter due to malfunction. outcomes of Primary Clinical Functional Patency or CVC-related bacteremia or death | 6 months |
| Number of Participants Who Had > 3 Months of Catheter Dependency After Arteriovenous Creation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tze-Woei Tan, MD | Banner University Medical Center Tucson/University of Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Center Tucson | Tucson | Arizona | 85724 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | One Stage Approach | 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. One stage approach: Upper extremity brachial basilic arteriovenous fistula will be created either using one stage or two stage approach. |
| FG001 | Two Stage Approach | 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. One stage approach: Upper extremity brachial basilic arteriovenous fistula will be created either using one stage or two stage approach. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | One Stage Approach | 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. One stage approach: Upper extremity brachial basilic arteriovenous fistula will be created either using one stage or two stage approach. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Had Successful Use of Arteriovenous Fistula for Dialysis | Functional clinical patency means the number of participants who were able to use their brachial basilic arteriovenous fistula (BBAVF) successfully for dialysis within 6 months of surgical creation. It refers to using two dialysis needles in at least 75% of dialysis sessions over four weeks without need for additional procedure or surgery, as determined by their providers. | Posted | Count of Participants | Participants | 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | One Stage Approach | 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. One stage approach: Upper extremity brachial basilic arteriovenous fistula will be created either using one stage or two stage approach. |
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Study was terminated early due to low enrollment and PI leaving the institution.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tze-Woei Tan | University of Arizona | 3234426835 | tze-woei.tan@med.usc.edu; ttan@arizona.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 30, 2020 | Jul 5, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 28, 2020 | Jul 5, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D001164 | Arteriovenous Fistula |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Assigned to either a one-stage or two-stage approach for brachial-basilic arteriovenous fistula (BBAVF) creation in a 1:1 ratio.
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|
Number of participants who had > 3 months of catheter dependency after arteriovenous fistula creation |
| 6 months |
| Patient-Reported Outcomes Measurement Information System Scores Over 6 Months | Average quality of life scores assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) for physical function, fatigue, sleep disturbance, and ability to participate in social roles and activities. Data are presented as T-score, which are standardized scores with a mean of 50 and a standard deviation for the reference population (typically the US general population). A T-score of 50 represents the population average. A higher T-score indicates more of the concept being measured and lower T-score indicate less. | 6-month |
| BG001 |
| Two Stage Approach |
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. One stage approach: Upper extremity brachial basilic arteriovenous fistula will be created either using one stage or two stage approach. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Dialysis | Count of Participants | Participants |
|
| OG001 |
| Two Stage Approach |
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. One stage approach: Upper extremity brachial basilic arteriovenous fistula will be created either using one stage or two stage approach. |
|
|
| Secondary | Number of Participants Who Had Catheter Related Complications | Number of participants with dialysis catheter related complications, including infection, procedure to exchange catheter due to malfunction. outcomes of Primary Clinical Functional Patency or CVC-related bacteremia or death | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Number of Participants Who Had > 3 Months of Catheter Dependency After Arteriovenous Creation | Number of participants who had > 3 months of catheter dependency after arteriovenous fistula creation | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Patient-Reported Outcomes Measurement Information System Scores Over 6 Months | Average quality of life scores assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) for physical function, fatigue, sleep disturbance, and ability to participate in social roles and activities. Data are presented as T-score, which are standardized scores with a mean of 50 and a standard deviation for the reference population (typically the US general population). A T-score of 50 represents the population average. A higher T-score indicates more of the concept being measured and lower T-score indicate less. | Participate did not complete PROMIS questionnaire. | Posted | Mean | Standard Deviation | score on a scale | 6-month |
|
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Two Stage Approach | 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. One stage approach: Upper extremity brachial basilic arteriovenous fistula will be created either using one stage or two stage approach. | 0 | 1 | 0 | 1 | 0 | 1 |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001165 | Arteriovenous Malformations |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D016157 | Vascular Fistula |
| D014652 | Vascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| Title | Measurements |
|---|---|
|
| Ability to participate in social roles and activities (T-score) |
|