Status:
TERMINATED
Bovine Carotid Artery Biologic Graft and Expanded Polytetrafluoroethylene for Permanent Hemodialysis Access
Lead Sponsor:
Johns Hopkins University
Conditions:
End Stage Renal Disease
Hemolysis
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
The investigators propose a randomized study to compare bovine carotid artery (BCA) biologic grafts and expanded polytetrafluoroethylene grafts (ePTFE) for permanent hemodialysis access.
Detailed Description
Arteriovenous grafts (AVG) remain reliable substitutes for permanent hemodialysis access in scenarios that preclude the placement of arteriovenous fistulae. There is scarcity of evidence to support th...
Eligibility Criteria
Inclusion
- Patients at least 18 years of age
- Have End Stage Renal Disease and are undergoing Arterio-Venous-Graft surgery
- Not Eligible to receive an Arterio-Venous-Fistula
- Provided written informed consent
- Agreed to return for all required clinical follow up for the study
Exclusion
- Eligible to receive an Arterio-Venous-Fistula
- Known allergic reaction or history of intolerance to any ePTFE or BCA components
- Local infection at AVG placement site at the time of surgery
- Patients with a bleeding disorder or who refuse blood transfusion
- Patients with an active malignancy
- Life expectancy less than 1 year
- Pregnant women or those planning on becoming pregnant for the duration of the study
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 12 2018
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03300024
Start Date
February 1 2015
End Date
February 12 2018
Last Update
May 21 2019
Active Locations (1)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21224