A Comparison of mNT-BBAVF and BCAVF in Hemodialysis Patients

NACompletedINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

April 30, 2016

Primary Completion Date

August 31, 2018

Study Completion Date

August 31, 2019

Conditions
Vascular Fistula
Interventions
PROCEDURE

mNT-BBAVF

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.

PROCEDURE

BCAVF

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.

Trial Locations (2)

200072

The Division of Nephrology & Rheumatology, Shanghai 10th People's Hospital, Shanghai

02903

Rhode Island Hospital/Brown University Medicine School, Providence

All Listed Sponsors
lead

Shanghai 10th People's Hospital

OTHER

NCT02519933 - A Comparison of mNT-BBAVF and BCAVF in Hemodialysis Patients | Biotech Hunter | Biotech Hunter