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

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).

Study Overview

• Status: Terminated
• Conditions: End Stage Renal Disease
• Intervention / Treatment: Device: GORE® Hybrid Vascular Graft; Device: Non-heparin bonded synthetic graft

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
    • Durham, North Carolina, United States, 27710
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: GORE® Hybrid Vascular Graft	Device: GORE® Hybrid Vascular Graft
Other: Non-heparin bonded synthetic graft	Device: Non-heparin bonded synthetic graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With a Prevalence of a Positive Poly-specific Enzyme Immunoassay (EIA) at Day 7 and/or Day 14 Time Points	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.	14 days after index procedure

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): January 20, 2017
• Study Completion (Actual): January 20, 2017

Study Registration Dates

• First Submitted: June 13, 2014
• First Submitted That Met QC Criteria: June 13, 2014
• First Posted (Estimate): June 17, 2014

Study Record Updates

• Last Update Posted (Actual): February 19, 2018
• Last Update Submitted That Met QC Criteria: February 15, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: End Stage Renal Disease; Hemodialysis; Vascular Graft
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: HVG 13-01