Clinical Trial: Continuous Suturing Versus Interrupted Clips for Brachiocephalic AV Fistula Creation

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Prospective Randomized Single Blinded Study of Continuous Suturing Versus Interrupted Clips for Brachiocephalic AV Fistula Creation

Brief Summary: The purpose of this study is to investigate a promising strategy to improve maturation and patency rates following creation of AV fistulas and assess whether an anastomosis performed with Anastoclips (interrupted, nonpenetrating) would produce better maturation and/or patency than one performed with conventional suturing techniques.

Detailed Summary: This will be a single blind (patient and dialysis center), prospective, randomized trial conducted at a single center. The study intervention will be randomization between conventional sutured anastomosis (Control group) and use of Anastoclips (Treatment group), which provide an interrupted closure without intimal penetration.
Sponsor: University of South Florida

Current Primary Outcome: Time to loss of primary patency [ Time Frame: one year post surgery ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Time to loss of secondary patency [ Time Frame: one year post surgery ]
  • Time to loss of assisted primary patency [ Time Frame: one year post surgery ]
  • Rate of functional maturation [ Time Frame: one year post surgery ]
    in patients on dialysis
  • Time to functional maturation [ Time Frame: one year post surgery ]
    in patients on dialysis
  • Rate of assumed maturation [ Time Frame: one year post surgery ]
    in patients not on dialysis
  • Time to assumed maturation [ Time Frame: one year post surgery ]
    in patients not on dialysis
  • Rate of complications [ Time Frame: 30 days post surgery ]
    thrombosis/thrombectomy, stenosis, skin erosion, limb swelling, steal syndrome, bleeding and hematoma formation at surgical site, surgical-site-related infection, access-related infection, rupture, revision
  • Rate of intervention [ Time Frame: five years post surgery ]
    to maintain patency
  • Operative cost [ Time Frame: duration of surgery ]
  • Overall cost [ Time Frame: time of surgery to time of hospital discharge (can range from 1 day to 1 week or more) ]
    Overall cost of surgery itself defined as from surgery to point of hospital discharge, anticipated to be in days
  • Time to loss of primary patency [ Time Frame: 5 years post surgery ]
  • Time to loss of assisted primary patency [ Time Frame: 5 years post surgery ]
  • Time to loss of secondary patency [ Time Frame: 5 years post surgery ]


Original Secondary Outcome: Same as current

Information By: University of South Florida

Dates:
Date Received: January 6, 2017
Date Started: February 2017
Date Completion: August 2024
Last Updated: February 16, 2017
Last Verified: January 2017