Comparison of Bovine Carotid Artery and Expanded Polytetrafluoroethylene (ePTFE) for Permanent Hemodialysis Access

Not Applicable

Completed

• Conditions: Kidney Failure; Renal Dialysis
• Interventions: Procedure: Grafts placement

• Registration Number: NCT01021839
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The investigators did a randomized control trial comparing bovine carotid artery grafts with ePTFE grafts for patients that need hemodialysis access. The goal of the study was to determine differences in primary and assisted patency rates and frequency of complications between these two types of grafts. The investigators' hypothesis was that bovine carotid artery grafts more closely mimic autologous tissue and therefore, would provide better patency and fewer complications.

Detailed Description

Objective: To understand how bovine carotid artery (BCA) grafts compare to cuffed polytetrafluoroethylene (ePTFE) grafts as conduits for hemodialysis access in terms of patency and complications.

Background: Many hemodialysis patients do not have adequate anatomy for native arteriovenous fistulas. In these patients, synthetic conduits remain the only option for permanent hemodialysis access. We sought to compare the standard cuffed ePTFE with bovine carotid artery grafts as this has not been undertaken since the 1970's.

Methods: Following Institutional Review Board approval, a prospective, randomized controlled trial was conducted enrolling 29 patients in the BCA group and 28 patients in the ePTFE group. Univariate and multivariate analysis was undertaken to understand factors that affect complications. Patency rates were calculated using the Kaplan-Meyer method.

Study Timeline

• Study Start: 2006-04
• Primary Completion: 2009-02
• Study Completion: 2009-06
• Status Verified: 2009-11
• Study First Submitted: 2009-11-18
• Study First Submitted QC: 2009-11-25
• Last Update Submitted: 2009-11-25
• Study First Posted: 2009-11-30
• Last Update Posted: 2009-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• Chronic kidney disease stage 4 or 5, in need of hemodialysis access

Exclusion Criteria

• Surgically suitable for a native arteriovenous fistula

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bovine Carotid Artery Graft	Grafts placement	-
Expanded Polytetrafluoroethylene Grafts	Grafts placement	-

Primary Outcome Measures

Name	Time	Method
Primary and Assisted Patency	6, 12, 18, 24 months

Secondary Outcome Measures

Name	Time	Method
patients were monitored for the following complications: thrombosis of the graft; graft infection; pseudoaneurysm formation; steal syndrome.	6,12,18 and 24 months

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States