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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 42
- Locations
- 4
- Primary Endpoint
- Number of Participants With a Prevalence of a Positive Poly-specific Enzyme Immunoassay (EIA) at Day 7 and/or Day 14 Time Points
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
GORE® Hybrid Vascular Graft
GORE® Hybrid Vascular Graft
Intervention: GORE® Hybrid Vascular Graft (Device)
Non-heparin bonded synthetic graft
Non-heparin bonded synthetic graft
Intervention: Non-heparin bonded synthetic graft (Device)
Outcomes
Primary Outcomes
Number of Participants With a Prevalence of a Positive Poly-specific Enzyme Immunoassay (EIA) at Day 7 and/or Day 14 Time Points
Time Frame: 14 days after index procedure
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 Outcomes
No secondary outcomes reported