Evaluation of Anti-platelet Factor 4/Heparin Antibodies in Hemodialysis Patients

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.

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).

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.