Compare Elbow mNT-BBAVF With Wrist RCAVF for Hemodialysis Access

NCT03701243 | Unknown

• 1 other identifier: mNT-BBAVF vs RCAVF
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

End Stage Renal Disease on Dialysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Immediate Vascular Access Failure

  72 hours

• Cumulative Patency

  1 year

• Early Dialysis Suitability Failure

  3 months

Study Arms (2)

mNT-BBAVF

EXPERIMENTAL

These patients will receive a modified non-transposed brachiobasilic arteriovenous fistula (mNT-BBAVF) at elbow for hemodialysis acess.

Procedure: mNT-BBAVF

RCAVF

ACTIVE COMPARATOR

These patients will receive a radiocephalic arteriovenous fistula (RCAVF) at wrist for hemodialysis acess.

Procedure: RCAVF

Interventions

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.

mNT-BBAVF

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.

RCAVF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200072, China

Location

Related Publications (1)

• 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.

  PMID: 27296523 BACKGROUND

Study Officials

• Ai Peng, MD, PhD

  Shanghai 10th People's Hospital of Tongji University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Changbin Li, MD

CONTACT

+86 13916907936; changbin_li@tongji.edu.cn

Dayong Hu, MD

CONTACT

+86 13585988609; hdy455@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: October 7, 2018
• First Posted: October 9, 2018
• Study Start: December 1, 2019
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2021
• Last Updated: September 25, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)