A Comparison of mNT-BBAVF and BCAVF in Hemodialysis Patients
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|ClinicalTrials.gov Identifier: NCT02519933|
Recruitment Status : Completed
First Posted : August 11, 2015
Last Update Posted : September 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Vascular Fistula||Procedure: mNT-BBAVF Procedure: BCAVF||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Comparison of Modified Non-transposed Brachiobasilic Arteriovenous Fistula and Brachiocephalic Arteriovenous Fistula in Hemodialysis Patients|
|Study Start Date :||April 2016|
|Actual Primary Completion Date :||August 31, 2018|
|Actual Study Completion Date :||August 31, 2019|
Active Comparator: mNT-BBAVF
Patients in Chronic Kidney Disease (CKD) stage 4-5 without previous dysfunctional fistula access
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.
Active Comparator: BCAVF
Patients in CKD stage 4-5 without previous dysfunctional fistula access
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 unassited patency [ Time Frame: 12 months ]The interval from the time of access creation to any first intervention (endovascular or surgical) designed to maintain or reestablish patency, access thrombosis.
- Cumulative patency [ Time Frame: 12 month ]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 [ Time Frame: 1 month ]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 [ Time Frame: 12 months ]Complications of both mNT-BBAVF and BCAVF groups within 12 months (thrombosis, stenosis and aneurysm).
- Calculated blood flow volumes of the corresponding fistula segments [ Time Frame: 12 months ]Blood flow volume (ml/min) = mean velocity (cm/s) * area (r2π) * 60 seconds.
- Diameters of the veins and arteries in the corresponding arm [ Time Frame: 12 months ]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. [ Time Frame: 12 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02519933
|United States, Rhode Island|
|Rhode Island Hospital/Brown University Medicine School|
|Providence, Rhode Island, United States, 02903|
|The Division of Nephrology & Rheumatology, Shanghai 10th People's Hospital|
|Shanghai, Shanghai, China, 200072|
|Principal Investigator:||AI Peng, M.D., Ph.D.||The Division of Nephrology & Rheumatology, Shanghai 10th People's Hospital|