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