Back to resultsEvaluation of Anti-platelet Factor 4/Heparin Antibodies in Hemodialysis Patients
Primary Purpose
End Stage Renal Disease
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GORE® Hybrid Vascular Graft
Non-heparin bonded synthetic graft
Sponsored by
About this trial
This is an interventional basic science trial for End Stage Renal Disease focused on measuring Hemodialysis, End Stage Renal Disease, Vascular Graft
Eligibility Criteria
Inclusion Criteria:
- The patient is not a candidate for a native fistula.
- The patient requires the creation of an upper arm vascular access graft for hemodialysis secondary to a diagnosis of End-Stage Renal Disease.
- The patient has been on hemodialysis for ≥1 month.
Exclusion Criteria:
- The patient is scheduled for a different surgical procedure within 30 days post Index Procedure.
- The patient has a known hypercoagulable disorder or bleeding disorder.
- The patient has had a previous instance of Heparin Induced Thrombocytopenia Type II (HIT type II) or has known sensitivity to heparin.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
GORE® Hybrid Vascular Graft
Non-heparin bonded synthetic graft
Arm Description
GORE® Hybrid Vascular Graft
Non-heparin bonded synthetic graft
Outcomes
Primary Outcome Measures
Number of Participants With a Prevalence of a Positive Poly-specific Enzyme Immunoassay (EIA) at Day 7 and/or Day 14 Time Points
Antibody screening was performed using a commercial poly-specific EIA that detects antibodies of any of the IgG, IgA, and / or IgM classes against PF4/polyvinyl sulfonate complexes, the EIA-GAM.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02165761
Brief Title
Evaluation of Anti-platelet Factor 4/Heparin Antibodies in Hemodialysis Patients
Official Title
Evaluation of Anti-platelet Factor 4/Heparin Antibodies in Hemodialysis Patients Implanted With the GORE® Hybrid Vascular Graft Versus Non-heparin Bonded Synthetic Vascular Grafts.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Terminated
Study Start Date
July 2014 (undefined)
Primary Completion Date
January 20, 2017 (Actual)
Study Completion Date
January 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
W.L.Gore & Associates
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To characterize the GORE® Hybrid Vascular Graft as compared to non-heparin bonded synthetic vascular grafts in terms of the prevalence and persistence of anti-platelet factor 4 / heparin antibodies (anti-PF4 / H antibodies).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
Hemodialysis, End Stage Renal Disease, Vascular Graft
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GORE® Hybrid Vascular Graft
Arm Type
Active Comparator
Arm Description
GORE® Hybrid Vascular Graft
Arm Title
Non-heparin bonded synthetic graft
Arm Type
Other
Arm Description
Non-heparin bonded synthetic graft
Intervention Type
Device
Intervention Name(s)
GORE® Hybrid Vascular Graft
Intervention Type
Device
Intervention Name(s)
Non-heparin bonded synthetic graft
Primary Outcome Measure Information:
Title
Number of Participants With a Prevalence of a Positive Poly-specific Enzyme Immunoassay (EIA) at Day 7 and/or Day 14 Time Points
Description
Antibody screening was performed using a commercial poly-specific EIA that detects antibodies of any of the IgG, IgA, and / or IgM classes against PF4/polyvinyl sulfonate complexes, the EIA-GAM.
Time Frame
14 days after index procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient is not a candidate for a native fistula.
The patient requires the creation of an upper arm vascular access graft for hemodialysis secondary to a diagnosis of End-Stage Renal Disease.
The patient has been on hemodialysis for ≥1 month.
Exclusion Criteria:
The patient is scheduled for a different surgical procedure within 30 days post Index Procedure.
The patient has a known hypercoagulable disorder or bleeding disorder.
The patient has had a previous instance of Heparin Induced Thrombocytopenia Type II (HIT type II) or has known sensitivity to heparin.
Facility Information:
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Anti-platelet Factor 4/Heparin Antibodies in Hemodialysis Patients
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