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

End Stage Renal Disease Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02165761
• Other study ID #: HVG 13-01
• Status: Terminated
• Phase: N/A
• First received: June 13, 2014
• Last updated: February 15, 2018
• Start date: July 2014
• Est. completion date: January 20, 2017

Study information

• Verified date: February 2018
• Source: W.L.Gore & Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 42
• Est. completion date: January 20, 2017
• Est. primary completion date: January 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Device:
• GORE® Hybrid Vascular Graft

• Non-heparin bonded synthetic graft

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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