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

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.

Study Overview

• Status: Unknown
• Conditions: End Stage Renal Disease on Dialysis
• Intervention / Treatment: Procedure: mNT-BBAVF; Procedure: RCAVF

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.

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200072
      • Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients with chronic kidney disease (CKD) stage 5 requiring hemodialysis (including pre-dialysis patients) and eligible for a native arteriovenous fistula;
2. Adult (age ≥ 18 years old);
3. Preoperative Doppler ultrasonography showing target vein diameter(s) ≥ 2.0 mm and target artery diameter(s) ≥ 2.0 mm;
4. Estimated life expectancy > 1 year;
5. Written informed consent obtained;
6. Patient is free of clinically significant conditions or illness that may compromise the procedure within 30 days prior to AVF creation

Exclusion Criteria:

1. Patients with a history of cerebral hemorrhage or gastrointestinal hemorrhage are excluded from the study;
2. New York Heart Association class III or IV heart failure;
3. Patients who are absent of median cubital vein and verified by preoperative Doppler ultrasonography are excluded from the study;
4. Known central venous stenosis, central vein narrowing > 50% or deep vein thrombosis based on imaging on the same side as the planned AVF creation;
5. Prior arm surgically created access in the planned treatment arm;
6. Immunosuppression (i.e. use of immunosuppressive medications to treat an active condition).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mNT-BBAVF; These patients will receive a modified non-transposed brachiobasilic arteriovenous fistula (mNT-BBAVF) at elbow for hemodialysis acess.	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.
Active Comparator: RCAVF; These patients will receive a radiocephalic arteriovenous fistula (RCAVF) at wrist for hemodialysis acess.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital
• Investigators: Principal Investigator: Ai Peng, MD, PhD, Shanghai 10th People's Hospital of Tongji University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2019
• Primary Completion (Anticipated): October 31, 2020
• Study Completion (Anticipated): October 31, 2021

Study Registration Dates

• First Submitted: October 7, 2018
• First Submitted That Met QC Criteria: October 7, 2018
• First Posted (Actual): October 9, 2018

Study Record Updates

• Last Update Posted (Actual): September 25, 2019
• Last Update Submitted That Met QC Criteria: September 23, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: mNT-BBAVF vs RCAVF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No