Evaluation of Anti-platelet Factor 4/Heparin Antibodies in Hemodialysis Patients
1 other identifier
interventional
42
1 country
4
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2014
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2014
CompletedFirst Posted
Study publicly available on registry
June 17, 2014
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 20, 2017
CompletedResults Posted
Study results publicly available
February 19, 2018
CompletedFebruary 19, 2018
February 1, 2018
2.6 years
June 13, 2014
January 18, 2018
February 15, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
GORE® Hybrid Vascular Graft
ACTIVE COMPARATORGORE® Hybrid Vascular Graft
Non-heparin bonded synthetic graft
OTHERNon-heparin bonded synthetic graft
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Unknown Facility
Hackensack, New Jersey, 07601, United States
Unknown Facility
Charlotte, North Carolina, 28207, United States
Unknown Facility
Durham, North Carolina, 27710, United States
Unknown Facility
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Suzy Palmer, CCRP
- Organization
- W.L. Gore and Associates, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2014
First Posted
June 17, 2014
Study Start
July 1, 2014
Primary Completion
January 20, 2017
Study Completion
January 20, 2017
Last Updated
February 19, 2018
Results First Posted
February 19, 2018
Record last verified: 2018-02