Hemodialysis Fistula Thrombosis
Conditions
Keywords
Renal Failure, End Stage, Blood Vessel Grafting, Hemodialysis, Surgical Arteriovenous Shunt
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.
Interventions
PROCEDUREProsthetic AV graft implantation
Surgical arteriovenous fistula creation with standard or propaten graft
Sponsors
Shaare Zedek Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patency of AV fistula | Study period |
Countries
Israel
Outcome results
None listed