Back to resultsEvaluation of Heparin Bonded Vascular Graft Versus Standard Graft in Prosthetic Arteriovenous Access for Hemodialysis
Primary Purpose
Hemodialysis Fistula Thrombosis
Status
Completed
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Prosthetic AV graft implantation
Sponsored by
About this trial
This is an interventional treatment trial for Hemodialysis Fistula Thrombosis focused on measuring Renal Failure, End Stage, Blood Vessel Grafting, Hemodialysis, Surgical Arteriovenous Shunt
Eligibility Criteria
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
Sites / Locations
- Shaare Zedek Medical Center, Jerusalem
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
propaten graft
Standard graft
Arm Description
Outcomes
Primary Outcome Measures
Patency of AV fistula
Secondary Outcome Measures
Full Information
NCT ID
NCT00737620
First Posted
August 17, 2008
Last Updated
October 29, 2012
Sponsor
Shaare Zedek Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00737620
Brief Title
Evaluation of Heparin Bonded Vascular Graft Versus Standard Graft in Prosthetic Arteriovenous Access for Hemodialysis
Official Title
Evaluation of Heparin Bonded Vascular Graft Versus Standard Graft in Prosthetic Arteriovenous Access for Hemodialysis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shaare Zedek Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodialysis Fistula Thrombosis
Keywords
Renal Failure, End Stage, Blood Vessel Grafting, Hemodialysis, Surgical Arteriovenous Shunt
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
propaten graft
Arm Type
Active Comparator
Arm Title
Standard graft
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Prosthetic AV graft implantation
Intervention Description
Surgical arteriovenous fistula creation with standard or propaten graft
Primary Outcome Measure Information:
Title
Patency of AV fistula
Time Frame
Study period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Shaare Zedek Medical Center, Jerusalem
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
25770987
Citation
Shemesh D, Goldin I, Hijazi J, Zaghal I, Berelowitz D, Verstandig A, Olsha O. A prospective randomized study of heparin-bonded graft (Propaten) versus standard graft in prosthetic arteriovenous access. J Vasc Surg. 2015 Jul;62(1):115-22. doi: 10.1016/j.jvs.2015.01.056. Epub 2015 Mar 12.
Results Reference
derived
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Evaluation of Heparin Bonded Vascular Graft Versus Standard Graft in Prosthetic Arteriovenous Access for Hemodialysis
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