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A Comparison of mNT-BBAVF and BCAVF in Hemodialysis Patients

Primary Purpose

Vascular Fistula

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
mNT-BBAVF
BCAVF
Sponsored by
Shanghai 10th People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vascular Fistula focused on measuring hemodialysis, vascular access

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age from 18 to 75 years;
  • Radial artery diameter <2.0 mm or cephalic vein diameter in the forearm <2.5 mm;
  • Brachial artery diameter ≥ 2 mm

Exclusion Criteria:

  • Stenosis or thrombosis present in the draining vein;
  • A history of peripheral ischemia in upper extremities;
  • Active local or systemic infections;
  • Inability to consent for the procedure;
  • Patients with previous dysfunctional forearm fistula.

Sites / Locations

  • Rhode Island Hospital/Brown University Medicine School
  • The Division of Nephrology & Rheumatology, Shanghai 10th People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

mNT-BBAVF

BCAVF

Arm Description

Patients in Chronic Kidney Disease (CKD) stage 4-5 without previous dysfunctional fistula access

Patients in CKD stage 4-5 without previous dysfunctional fistula access

Outcomes

Primary Outcome Measures

Primary unassited patency
The interval from the time of access creation to any first intervention (endovascular or surgical) designed to maintain or reestablish patency, access thrombosis.

Secondary Outcome Measures

Cumulative patency
The interval from the time of access placement to access abandonment, including intervening (all surgical and endovascular interventions) designed to reestablish the functionality of thrombosed access.
Short-term complications
Complications of both mNT-BBAVF and BCAVF groups within 1 month (thrombosis, failure of maturation, bleeding, steal syndrome, arm edema and severe arm pain)
Long-term complications
Complications of both mNT-BBAVF and BCAVF groups within 12 months (thrombosis, stenosis and aneurysm).
Calculated blood flow volumes of the corresponding fistula segments
Blood flow volume (ml/min) = mean velocity (cm/s) * area (r2π) * 60 seconds.
Diameters of the veins and arteries in the corresponding arm
Vessels's diameters (cm) of the relevant veins (proximal cephalic vein, distal cephalic vein, distal basilic vein) and arteries (Subclavian artery, axillary artery, brachial artery, radial artery and ulnar artery) in the corresponding arm.
Blood flow velocities of the veins and arteries in the corresponding arm.
Blood flow velocities (cm/s) of the relevant veins (proximal cephalic vein, distal cephalic vein, distal basilic vein) and arteries (Subclavian artery, axillary artery, brachial artery, radial artery and ulnar artery) in the corresponding arm.

Full Information

First Posted
July 21, 2015
Last Updated
September 23, 2019
Sponsor
Shanghai 10th People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02519933
Brief Title
A Comparison of mNT-BBAVF and BCAVF in Hemodialysis Patients
Official Title
A Comparison of Modified Non-transposed Brachiobasilic Arteriovenous Fistula and Brachiocephalic Arteriovenous Fistula in Hemodialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
August 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai 10th People's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A well-functioning vascular access is essential for effective hemodialysis. The native arteriovenous fistula (AVF) is the preferred vascular access because of the lower thrombosis and infection risks compared to either synthetic arteriovenous grafts or central venous catheters. Brachiocephalic arteriovenous fistula (BCAVF) and transposed brachiobasilic arteriovenous fistula (T-BBAVF) are recommended when there is either a primary failure or no suitable vessels for the forearm fistula. However, BCAVF is frequently cannulated at the antecubital fossa, the risks of stenosis and thrombosis are high, which will compromise proper BCAVF function and survival. T-BBAVF is not only technically challenging, but also associates with severe arm swelling and pain. Thus, the investigators introduced a novel modified Non-transposed brachiobasilic arteriovenous fistula (mNT-BBAVF) for long-term hemodialysis patients. To confirm its efficacy, a prospective clinical study would be carried out.
Detailed Description
The study aims to compare the outcomes of a novel modified Non-transposed brachiobasilic arteriovenous fistula (mNT-BBAVF) and the standard brachiocephalic arteriovenous fistula (BCAVF) for long-term hemodialysis patients. Briefly, in mNT-BBAVF, a side-to-side anastomosis between the brachial artery and non-transposed proximal basilic vein is disposed, followed by the ligation of the vein above anastomosis. All the perforating in the surgical field should be ligated. All patients will be followed up for 12 months after surgeries. The outcomes includes: hemodynamic parameters (vessels's diameters, blood flow velocities and blood volumes) detected by ultrasound in 12 months, Complications in 1-month and 12-month, primary patency and secondary patency (cumulative patency).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Fistula
Keywords
hemodialysis, vascular access

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mNT-BBAVF
Arm Type
Active Comparator
Arm Description
Patients in Chronic Kidney Disease (CKD) stage 4-5 without previous dysfunctional fistula access
Arm Title
BCAVF
Arm Type
Active Comparator
Arm Description
Patients in CKD stage 4-5 without previous dysfunctional fistula access
Intervention Type
Procedure
Intervention Name(s)
mNT-BBAVF
Intervention Description
mNT-BBAVF was performed under local anesthesia. A transverse incision of approximately 4 cm was made in the antecubital area. The basilic vein was isolated, and its side branches were ligated; followed by the isolation of brachial artery. A venotomy of 5 mm was performed, followed an arteriotomy of 5 mm. The two vessels then had a side-to-side anastomosis, followed by the ligation of the vein above anastomosis. All the perforating veins located in an area 2-4 cm down the antecubital fossa from anastomosis were separated and ligated carefully. After surgeries, all patients will be followed up for 12 months. The outcomes are patency (primary unassisted patency and secondary), complications and hemodynamic parameters (diameters, blood velocities and blood volume) detected by Ultrasound.
Intervention Type
Procedure
Intervention Name(s)
BCAVF
Intervention Description
BCAVF was performed under local anesthesia. A transverse incision of approximately 4 cm in length was made in the medial antecubital area. The cephalic vein was isolated, followed by the isolation of brachial artery. The distal end of cephalic vein was ligated and dissected. Patency of the proximal vein was verified by the warmed saline injection. The artery was then incised after clamping, and an end-to-side anastomosis (4-0 silk suture) between the cephalic vein and the brachial artery was performed. At last the skin is sutured (1-0 silk suture). At last the skin is sutured. After surgeries, all patients will be followed up for 12 months. The outcomes are patency (primary unassisted patency and secondary), complications and hemodynamic parameters detected by Ultrasound.
Primary Outcome Measure Information:
Title
Primary unassited patency
Description
The interval from the time of access creation to any first intervention (endovascular or surgical) designed to maintain or reestablish patency, access thrombosis.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Cumulative patency
Description
The interval from the time of access placement to access abandonment, including intervening (all surgical and endovascular interventions) designed to reestablish the functionality of thrombosed access.
Time Frame
12 month
Title
Short-term complications
Description
Complications of both mNT-BBAVF and BCAVF groups within 1 month (thrombosis, failure of maturation, bleeding, steal syndrome, arm edema and severe arm pain)
Time Frame
1 month
Title
Long-term complications
Description
Complications of both mNT-BBAVF and BCAVF groups within 12 months (thrombosis, stenosis and aneurysm).
Time Frame
12 months
Title
Calculated blood flow volumes of the corresponding fistula segments
Description
Blood flow volume (ml/min) = mean velocity (cm/s) * area (r2π) * 60 seconds.
Time Frame
12 months
Title
Diameters of the veins and arteries in the corresponding arm
Description
Vessels's diameters (cm) of the relevant veins (proximal cephalic vein, distal cephalic vein, distal basilic vein) and arteries (Subclavian artery, axillary artery, brachial artery, radial artery and ulnar artery) in the corresponding arm.
Time Frame
12 months
Title
Blood flow velocities of the veins and arteries in the corresponding arm.
Description
Blood flow velocities (cm/s) of the relevant veins (proximal cephalic vein, distal cephalic vein, distal basilic vein) and arteries (Subclavian artery, axillary artery, brachial artery, radial artery and ulnar artery) in the corresponding arm.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age from 18 to 75 years; Radial artery diameter <2.0 mm or cephalic vein diameter in the forearm <2.5 mm; Brachial artery diameter ≥ 2 mm Exclusion Criteria: Stenosis or thrombosis present in the draining vein; A history of peripheral ischemia in upper extremities; Active local or systemic infections; Inability to consent for the procedure; Patients with previous dysfunctional forearm fistula.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AI Peng, M.D., Ph.D.
Organizational Affiliation
The Division of Nephrology & Rheumatology, Shanghai 10th People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rhode Island Hospital/Brown University Medicine School
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
The Division of Nephrology & Rheumatology, Shanghai 10th People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200072
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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A Comparison of mNT-BBAVF and BCAVF in Hemodialysis Patients

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