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Investigator plan to conduct a multicenter, open-labelled, randomized study to compare the primary patency and safety of elbow mNT-BBAVF and wrist RCAVF in hemodialysis patients.
Although wrist radiocephalic arteriovenous fistula (RCAVF) has been recommended as first preferred fistula in many clinical practical guidelines for vascular access, there are no randomized controlled trials (RCTs) comparing the recommended anatomic order of distal-to-proximal access construction up to now. A modified non-transposed brachiobasilic arteriovenous fistula (mNT-BBAVF) that has a long length of suitable superficial vein for cannulation and a sufficient blood flow for effective dialysis has been introduced by investigator for several years. In addition, mNT-BBAVF has good primary patency and a low risk of complication and leave opportunities for further procedures in the event of failure. Investigator plan to conduct a multicenter, open-labelled, randomized study to compare the primary patency and safety of elbow mNT-BBAVF and wrist RCAVF in hemodialysis patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mNT-BBAVF | Experimental | These patients will receive a modified non-transposed brachiobasilic arteriovenous fistula (mNT-BBAVF) at elbow for hemodialysis acess. |
|
| RCAVF | Active Comparator | These patients will receive a radiocephalic arteriovenous fistula (RCAVF) at wrist for hemodialysis acess. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mNT-BBAVF | Procedure | Briefly, to construct an mNT-BBAVF, an incision is made on the ulnar side of the elbow. The brachial artery and basilic vein are then isolated, and a side-to-side anastomosis is performed without transposition of the basilic vein. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Unassisted Patency | This is the time of access creation or placement until any first intervention to maintain or restore blood flow | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Immediate Vascular Access Failure | This is an access that has either no appearance of or a loss of bruit or thrill within 72 hours of creation | 72 hours |
| Cumulative Patency | This is the time of access creation or placement until access abandonment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Changbin Li, MD | Contact | +86 13916907936 | changbin_li@tongji.edu.cn | |
| Dayong Hu, MD | Contact | +86 13585988609 | hdy455@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ai Peng, MD, PhD | Shanghai 10th People's Hospital of Tongji University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital | Shanghai | Shanghai Municipality | 200072 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27296523 | Background | Hu D, Li C, Sun L, Zhou C, Li X, Ai Z, Tang J, Peng A. A modified nontransposed brachiobasilic arteriovenous fistula versus brachiocephalic arteriovenous fistula for maintenance hemodialysis access. J Vasc Surg. 2016 Oct;64(4):1059-65. doi: 10.1016/j.jvs.2016.03.450. Epub 2016 Jun 11. |
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| RCAVF | Procedure | Briefly, to construct a wrist RCAVF, an incision is made on the radial side of the wrist. The radial artery and cephalic vein are then isolated, and a end-to-side anastomosis is performed. |
|
| 1 year |
| Early Dialysis Suitability Failure | This is an access that, despite radiological or surgical intervention, cannot be used successfully for dialysis by the third month following its creation. | 3 months |