Comparison of Bovine Carotid Artery and Expanded Polytetrafluoroethylene (ePTFE) for Permanent Hemodialysis Access
NCT ID: NCT01021839
Last Updated: 2009-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
57 participants
INTERVENTIONAL
2006-04-30
2009-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Bovine Carotid Artery Graft
Grafts placement
Graft placement (upper or lower extremity); surgical or radiographic revision as needed.
Expanded Polytetrafluoroethylene Grafts
Grafts placement
Graft placement (upper or lower extremity); surgical or radiographic revision as needed.
Interventions
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Grafts placement
Graft placement (upper or lower extremity); surgical or radiographic revision as needed.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Artegraft, Inc.
INDUSTRY
Massachusetts General Hospital
OTHER
Responsible Party
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Massachusetts General Hospital
Principal Investigators
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Tatsuo Kawai, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Other Identifiers
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2006p-000081
Identifier Type: -
Identifier Source: org_study_id