Trial Outcomes & Findings for Evaluation of Anti-platelet Factor 4/Heparin Antibodies in Hemodialysis Patients (NCT NCT02165761)
NCT ID: NCT02165761
Last Updated: 2018-02-19
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
42 participants
Primary outcome timeframe
14 days after index procedure
Results posted on
2018-02-19
Participant Flow
Participant milestones
| Measure |
GORE® Hybrid Vascular Graft
Subjects Randomized to the GORE® Hybrid Vascular Graft
|
Non-heparin Bonded Synthetic Graft
Subjects Randomized to the Non-heparin bonded synthetic graft
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
19
|
|
Overall Study
COMPLETED
|
4
|
5
|
|
Overall Study
NOT COMPLETED
|
19
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Anti-platelet Factor 4/Heparin Antibodies in Hemodialysis Patients
Baseline characteristics by cohort
| Measure |
GORE® Hybrid Vascular Graft
n=23 Participants
GORE® Hybrid Vascular Graft\>
\> GORE® Hybrid Vascular Graft
|
Non-heparin Bonded Synthetic Graft
n=19 Participants
Non-heparin bonded synthetic graft\>
\> Non-heparin bonded synthetic graft
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.8 years
STANDARD_DEVIATION 12.9 • n=99 Participants
|
58.7 years
STANDARD_DEVIATION 12.2 • n=107 Participants
|
60.4 years
STANDARD_DEVIATION 12.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
23 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 14 days after index procedurePopulation: 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.
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.
Outcome measures
| Measure |
GORE® Hybrid Vascular Graft
n=19 Participants
GORE® Hybrid Vascular Graft \>
\> GORE® Hybrid Vascular Graft
|
Non-heparin Bonded Synthetic Graft
n=16 Participants
Non-heparin bonded synthetic graft \>
\> 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
|
3 Participants
|
2 Participants
|
Adverse Events
Hybrid Vascular Graft (Test)
Serious events: 6 serious events
Other events: 4 other events
Deaths: 1 deaths
Non-Heparin Synthetic Graft (Control)
Serious events: 5 serious events
Other events: 8 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Hybrid Vascular Graft (Test)
n=23 participants at risk
Hybrid Vascular Graft (Test)
|
Non-Heparin Synthetic Graft (Control)
n=19 participants at risk
Non-Heparin Synthetic Graft (Control)
|
|---|---|---|
|
General disorders
Unsteady gait
|
4.3%
1/23 • 2 years, 3 months
|
0.00%
0/19 • 2 years, 3 months
|
|
General disorders
Weakness
|
4.3%
1/23 • 2 years, 3 months
|
0.00%
0/19 • 2 years, 3 months
|
|
Infections and infestations
Cellulitis of legs
|
0.00%
0/23 • 2 years, 3 months
|
5.3%
1/19 • 2 years, 3 months
|
|
Infections and infestations
Gangrene
|
4.3%
1/23 • 2 years, 3 months
|
0.00%
0/19 • 2 years, 3 months
|
|
Infections and infestations
Graft infection
|
4.3%
1/23 • 2 years, 3 months
|
0.00%
0/19 • 2 years, 3 months
|
|
Infections and infestations
Pneumonia
|
4.3%
1/23 • 2 years, 3 months
|
0.00%
0/19 • 2 years, 3 months
|
|
Infections and infestations
Septic shock
|
0.00%
0/23 • 2 years, 3 months
|
5.3%
1/19 • 2 years, 3 months
|
|
Infections and infestations
Sigmoid diverticulitis
|
0.00%
0/23 • 2 years, 3 months
|
5.3%
1/19 • 2 years, 3 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/23 • 2 years, 3 months
|
5.3%
1/19 • 2 years, 3 months
|
|
Injury, poisoning and procedural complications
Motor vehicle accident
|
4.3%
1/23 • 2 years, 3 months
|
0.00%
0/19 • 2 years, 3 months
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
4.3%
1/23 • 2 years, 3 months
|
0.00%
0/19 • 2 years, 3 months
|
|
Metabolism and nutrition disorders
Adult failure to thrive
|
4.3%
1/23 • 2 years, 3 months
|
0.00%
0/19 • 2 years, 3 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/23 • 2 years, 3 months
|
5.3%
1/19 • 2 years, 3 months
|
|
Nervous system disorders
Seizure
|
0.00%
0/23 • 2 years, 3 months
|
5.3%
1/19 • 2 years, 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/23 • 2 years, 3 months
|
5.3%
1/19 • 2 years, 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion recurrent
|
0.00%
0/23 • 2 years, 3 months
|
5.3%
1/19 • 2 years, 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/23 • 2 years, 3 months
|
5.3%
1/19 • 2 years, 3 months
|
|
Vascular disorders
Hypotension
|
4.3%
1/23 • 2 years, 3 months
|
0.00%
0/19 • 2 years, 3 months
|
Other adverse events
| Measure |
Hybrid Vascular Graft (Test)
n=23 participants at risk
Hybrid Vascular Graft (Test)
|
Non-Heparin Synthetic Graft (Control)
n=19 participants at risk
Non-Heparin Synthetic Graft (Control)
|
|---|---|---|
|
General disorders
Peripheral edema
|
0.00%
0/23 • 2 years, 3 months
|
5.3%
1/19 • 2 years, 3 months
|
|
Injury, poisoning and procedural complications
Arteriovenous graft thrombosis
|
4.3%
1/23 • 2 years, 3 months
|
5.3%
1/19 • 2 years, 3 months
|
|
Investigations
Venous pressure increased
|
0.00%
0/23 • 2 years, 3 months
|
5.3%
1/19 • 2 years, 3 months
|
|
Nervous system disorders
Numbness in hand
|
0.00%
0/23 • 2 years, 3 months
|
5.3%
1/19 • 2 years, 3 months
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
0.00%
0/23 • 2 years, 3 months
|
5.3%
1/19 • 2 years, 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/23 • 2 years, 3 months
|
5.3%
1/19 • 2 years, 3 months
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/23 • 2 years, 3 months
|
5.3%
1/19 • 2 years, 3 months
|
|
Vascular disorders
Hematoma
|
0.00%
0/23 • 2 years, 3 months
|
5.3%
1/19 • 2 years, 3 months
|
|
Vascular disorders
Steal syndrome
|
13.0%
3/23 • 2 years, 3 months
|
10.5%
2/19 • 2 years, 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60