Evaluation of Anti-platelet Factor 4/Heparin Antibodies in Hemodialysis Patients
| Status: | Terminated |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/8/2017 |
| Start Date: | July 2014 |
| End Date: | January 20, 2017 |
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).
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.
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