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

Stopped early · Not applicable

Conditions studied: End Stage Renal Disease

In brief

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).

Key facts

Study ID

NCT02165761

Run by

W.L.Gore & Associates

People needed

42

Starts

2014-07-01

Expected to finish

2017-01-20

Last updated by the study team

2018-02-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Hackensack, New Jersey, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Durham, North Carolina, United States
• Study site — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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