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

W.L. Gore & Associates

Status: Terminated

Conditions: End Stage Renal Disease

Treatments: Device: GORE® Hybrid Vascular Graft; Device: Non-heparin bonded synthetic graft

Study type: Interventional

Funder types: Industry

Identifiers

NCT02165761

HVG 13-01

Details and patient eligibility

About

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).

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

GORE® Hybrid Vascular Graft

Active Comparator group

Description:

GORE® Hybrid Vascular Graft

Treatment:

Device: GORE® Hybrid Vascular Graft

Non-heparin bonded synthetic graft

Other group

Description:

Non-heparin bonded synthetic graft

Treatment:

Device: Non-heparin bonded synthetic graft