NCT03701243

Compare Elbow mNT-BBAVF With Wrist RCAVF for Hemodialysis Access

A Multicenter, Open-labelled, Randomized Study to Compare the Primary Patency and Safety of Elbow Modified Non-transposed Brachiobasilic Arteriovenous Fistula With Wrist Radiocephalic Arteriovenous Fistula in Hemodialysis Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Shanghai 10th People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• End Stage Renal Disease on Dialysis

Interventions

Type	Name	Description
PROCEDURE	mNT-BBAVF	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.
PROCEDURE	RCAVF	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.

Timeline

• Start date: 2019-12-01
• Primary completion: 2020-10-31
• Completion: 2021-10-31
• First posted: 2018-10-09
• Last updated: 2019-09-25

Locations

1 site across 1 country: China