End Stage Renal Disease
Conditions
Keywords
Hemodialysis, End Stage Renal Disease, Vascular Graft
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).
Interventions
DEVICEGORE® Hybrid Vascular Graft
DEVICENon-heparin bonded synthetic graft
Sponsors
W.L.Gore & Associates
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GORE® Hybrid Vascular Graft GORE® Hybrid Vascular Graft\>
\> GORE® Hybrid Vascular Graft | 23 |
| Non-heparin Bonded Synthetic Graft Non-heparin bonded synthetic graft\>
\> Non-heparin bonded synthetic graft | 19 |
| Total | 42 |
Baseline characteristics
| Characteristic | GORE® Hybrid Vascular Graft | Total | Non-heparin Bonded Synthetic Graft |
|---|---|---|---|
| Age, Continuous | 61.8 years STANDARD_DEVIATION 12.9 | 60.4 years STANDARD_DEVIATION 12.5 | 58.7 years STANDARD_DEVIATION 12.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants | 42 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 34 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 8 Participants | 4 Participants |
| Region of Enrollment United States | 23 Participants | 42 Participants | 19 Participants |
| Sex: Female, Male Female | 14 Participants | 23 Participants | 9 Participants |
| Sex: Female, Male Male | 9 Participants | 19 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 23 | 1 / 19 |
| other Total, other adverse events | 4 / 23 | 8 / 19 |
| serious Total, serious adverse events | 6 / 23 | 5 / 19 |
Outcome results
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.
Time frame: 14 days after index procedure
Population: In the GORE® Hybrid Vascular Graft Group 19 out of 23 participants had obtained a serology sample at Day 7 and/or Day 14 for analysis.~In the Non-heparin bonded synthetic graft Group 16 out of 19 participants had obtained a serology sample at Day 7 and/or Day 14 for analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GORE® Hybrid Vascular Graft | Number of Participants With a Prevalence of a Positive Poly-specific Enzyme Immunoassay (EIA) at Day 7 and/or Day 14 Time Points | 3 Participants |
| Non-heparin Bonded Synthetic Graft | Number of Participants With a Prevalence of a Positive Poly-specific Enzyme Immunoassay (EIA) at Day 7 and/or Day 14 Time Points | 2 Participants |