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

Not Applicable

Terminated

• Conditions: End Stage Renal Disease
• Interventions: Device: Non-heparin bonded synthetic graft; Device: GORE® Hybrid Vascular Graft

• Registration Number: NCT02165761
• Lead Sponsor: W.L.Gore & Associates

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-13
• Study First Submitted QC: 2014-06-13
• Study First Posted: 2014-06-17
• Study Start: 2014-07
• Primary Completion: 2017-01-20
• Study Completion: 2017-01-20
• Results First Submitted: 2018-01-18
• Status Verified: 2018-02
• Results First Submitted QC: 2018-02-15
• Last Update Submitted: 2018-02-15
• Results First Posted: 2018-02-19
• Last Update Posted: 2018-02-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 42

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-heparin bonded synthetic graft	Non-heparin bonded synthetic graft	Non-heparin bonded synthetic graft
GORE® Hybrid Vascular Graft	GORE® Hybrid Vascular Graft	GORE® Hybrid Vascular Graft

Primary Outcome Measures

Name	Time	Method
Number of Participants With a Prevalence of a Positive Poly-specific Enzyme Immunoassay (EIA) at Day 7 and/or Day 14 Time Points	14 days after index procedure	Antibody screening was performed using a commercial poly-specific EIA that detects antibodies of any of the IgG, IgA, and / or IgM classes against PF4/polyvinyl sulfonate complexes, the EIA-GAM.