Ignite Creation Date:
2024-05-06 @ 7:21 AM
Last Modification Date:
2024-10-26 @ 11:47 AM
Study NCT ID:
NCT02519933
Status:
COMPLETED
Last Update Posted:
2019-09-25
First Post:
2015-07-21
Brief Title:
A Comparison of mNT-BBAVF and BCAVF in Hemodialysis Patients
Sponsor:
Shanghai 10th Peoples Hospital
Organization:
Shanghai 10th Peoples Hospital
Study Overview
Official Title:
A Comparison of Modified Non-transposed Brachiobasilic Arteriovenous Fistula and Brachiocephalic Arteriovenous Fistula in Hemodialysis Patients
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 vesselss 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None