Evaluation of Heparin Bonded Vascular Graft Versus Standard Graft in Prosthetic Arteriovenous Access for Hemodialysis

Hemodialysis Fistula Thrombosis Clinical Trial

Official title:

Evaluation of Heparin Bonded Vascular Graft Versus Standard Graft in Prosthetic Arteriovenous Access for Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00737620
• Other study ID #: 11111
• Status: Completed
• Phase: Phase 4
• First received: August 17, 2008
• Last updated: October 29, 2012
• Start date: March 2008

Study information

• Verified date: December 2011
• Source: Shaare Zedek Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The majority of bridge graft fistula with polytetrafluoroethylene (PTFE) for hemodialysis access will develop stenosis at the venous anastomosis and eventually will fail. Aspirin have been used for many years as a prophylactic drug therapy to prevent thrombosis but good clinical evidence for its benefit is lacking. Many drugs have been used to reduce intimal hyperplasia in animal models. Until recently there has been little success in clinical trials of anti-inflammatory, antiproliferative, antiplatelet, antithrombotic or calcium channel blocking drugs. Recently a major breakthrough was done by GORE when introducing the new heparin bonded PTFE graft by covalent attachment. This trial is planed to assess and compare between the GORE-TEX® PROPATEN vascular graft versus unmodified ePTFE grafts the patency and complication.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All the patients who are scheduled for the creation of a new prosthetic access with informed consent will be enrolled in the trial

• Investigators will attempt to enroll a male:female ratio of patients representative of their current patient population

Exclusion Criteria:

• Anticoagulation therapy

Related Conditions & MeSH terms

• Fistula
• Hemodialysis Fistula Thrombosis
• Thrombosis

Intervention

Procedure:
• Prosthetic AV graft implantation
Surgical arteriovenous fistula creation with standard or propaten graft

Locations

Country	Name	City	State
Israel	Shaare Zedek Medical Center, Jerusalem	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patency of AV fistula		Study period