Trial Outcomes & Findings for HeRO Graft Compared to Permanent Catheters for End Stage Renal Disease (ESRD) Patients Receiving Hemodialysis (NCT NCT01343251)
NCT ID: NCT01343251
Last Updated: 2017-09-08
Results Overview
Compare mortality rate between study arms
COMPLETED
33 participants
1 year
2017-09-08
Participant Flow
Participant milestones
| Measure |
HeRO Graft
patients who are evaluated and receive a Hemodialysis Reliable Outflow (HeRO) graft implant for hemodialysis
|
Control
control group of non-HeRO patients who are evaluated but do not receive a HeRO graft for any reason
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
17
|
|
Overall Study
COMPLETED
|
16
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
HeRO Graft Compared to Permanent Catheters for End Stage Renal Disease (ESRD) Patients Receiving Hemodialysis
Baseline characteristics by cohort
| Measure |
HeRO Graft
n=16 Participants
patients who are evaluated and receive a HeRO graft implant for hemodialysis
|
Control
n=17 Participants
control group of non-HeRO patients who are evaluated but do not receive a HeRO graft for any reason
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.69 years
STANDARD_DEVIATION 11.08 • n=5 Participants
|
63.12 years
STANDARD_DEVIATION 11.49 • n=7 Participants
|
60.00 years
STANDARD_DEVIATION 11.38 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
17 participants
n=7 Participants
|
33 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearCompare mortality rate between study arms
Outcome measures
| Measure |
HeRO Graft
n=16 Participants
HeRO Graft Recipients
|
Control
n=17 Participants
HeRO eligible patients who did not receive HeRO
|
|---|---|---|
|
Mortality
|
18.8 percentage of participants who died
|
29.4 percentage of participants who died
|
SECONDARY outcome
Timeframe: 1 yearCompare incidence of infection between study arms
Outcome measures
| Measure |
HeRO Graft
n=16 Participants
HeRO Graft Recipients
|
Control
n=17 Participants
HeRO eligible patients who did not receive HeRO
|
|---|---|---|
|
Infection Rate (Percentage of Participants With at Least One Infection)
|
25.0 Percentage of Patients
|
64.7 Percentage of Patients
|
SECONDARY outcome
Timeframe: 1 yearPopulation: The number of completed tests varied by time point and study group. The number of completed tests for Test 1, Test 2, Test 3, and Test 4 was 14, 13, 10, and 8 for the HeRO Graft group and 17, 13, 7, and 4 for the Control group, respectively. Only completed tests were included in the analysis.
Compare the RAND Short Form (SF)-36 Health Survey, Total Test Scores at baseline, 3, 6, and 12 months between study arms. Total test scores range on a scale from 0-100, with the lower the score equating to more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. The total score is calculated using a methodology described by the RAND Corporation, which assigns a recoded value to each survey item. Recoded items are averaged amongst scales and the total score is an average of the eight sections. (http://www.rand.org/content/dam/rand/www/external/health/surveys\_tools/mos/mos\_core\_36item\_scoring.pdf).
Outcome measures
| Measure |
HeRO Graft
n=16 Participants
HeRO Graft Recipients
|
Control
n=17 Participants
HeRO eligible patients who did not receive HeRO
|
|---|---|---|
|
Quality of Life
Test 1 (Baseline)
|
58.06 units on a scale
Standard Deviation 25.49
|
51.30 units on a scale
Standard Deviation 28.78
|
|
Quality of Life
Test 2 (3 Months)
|
56.30 units on a scale
Standard Deviation 23.78
|
55.22 units on a scale
Standard Deviation 22.40
|
|
Quality of Life
Test 3 (6 Months)
|
58.44 units on a scale
Standard Deviation 22.08
|
53.53 units on a scale
Standard Deviation 23.49
|
|
Quality of Life
Test 4 (12 Months)
|
60.41 units on a scale
Standard Deviation 18.06
|
20.14 units on a scale
Standard Deviation 4.67
|
SECONDARY outcome
Timeframe: 1 yearCompare vascular intervention rates between study arms. The vascular interventions which were included were: Angioplasty, Thrombectomy, Arteriovenous (AV) Fistulogram/Diagnostic Angiogram, Banding, Access Removal, Access Exchange, Access Revision, Creation of New Access, and any combination of these interventions which were performed simultaneously.
Outcome measures
| Measure |
HeRO Graft
n=16 Participants
HeRO Graft Recipients
|
Control
n=17 Participants
HeRO eligible patients who did not receive HeRO
|
|---|---|---|
|
Intervention Rate (Percentage of Participants Who Required at Least One Intervention While on Study)
|
93.8 percentage of participants
|
64.7 percentage of participants
|
SECONDARY outcome
Timeframe: 1 yearCompare incidence of hospitalization (for any reason) between study arms. Reasons for hospitalizations included: infection, cardiac problems, bleeding, vascular access thrombosis, fall (injury), hematuria, fluid overload, peripheral neuropathy, pulmonary embolism, edema, and shortness of breath.
Outcome measures
| Measure |
HeRO Graft
n=16 Participants
HeRO Graft Recipients
|
Control
n=17 Participants
HeRO eligible patients who did not receive HeRO
|
|---|---|---|
|
Hospitalization Rate (Percentage of Participants Who Were Hospitalized at Least Once While on Study)
|
62.5 Percentage of patients
|
64.7 Percentage of patients
|
Adverse Events
HeRO Graft
Control
Serious adverse events
| Measure |
HeRO Graft
n=16 participants at risk
HeRO Graft recipients
|
Control
n=17 participants at risk
HeRO eligible patients who did not receive a HeRO Graft
|
|---|---|---|
|
Blood and lymphatic system disorders
Bleeding
|
12.5%
2/16 • Number of events 2 • 1 year
|
0.00%
0/17 • 1 year
|
|
Blood and lymphatic system disorders
Pulmonary Embolism
|
6.2%
1/16 • Number of events 1 • 1 year
|
0.00%
0/17 • 1 year
|
|
Cardiac disorders
Arteriosclerotic Heart Disease
|
6.2%
1/16 • Number of events 1 • 1 year
|
0.00%
0/17 • 1 year
|
|
Cardiac disorders
Chest Pain
|
6.2%
1/16 • Number of events 1 • 1 year
|
5.9%
1/17 • Number of events 1 • 1 year
|
|
Cardiac disorders
Congestive Heart Failure
|
0.00%
0/16 • 1 year
|
11.8%
2/17 • Number of events 3 • 1 year
|
|
Cardiac disorders
Pulmonary Hypertension
|
6.2%
1/16 • Number of events 1 • 1 year
|
0.00%
0/17 • 1 year
|
|
Cardiac disorders
Syncope
|
0.00%
0/16 • 1 year
|
5.9%
1/17 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
GI Bleeding
|
0.00%
0/16 • 1 year
|
5.9%
1/17 • Number of events 1 • 1 year
|
|
Cardiac disorders
Death-Cardiac Arrest
|
0.00%
0/16 • 1 year
|
5.9%
1/17 • Number of events 1 • 1 year
|
|
Infections and infestations
Death-Sepsis
|
0.00%
0/16 • 1 year
|
5.9%
1/17 • Number of events 1 • 1 year
|
|
General disorders
Death-Unknown Cause
|
18.8%
3/16 • Number of events 3 • 1 year
|
17.6%
3/17 • Number of events 3 • 1 year
|
|
Infections and infestations
Infection
|
37.5%
6/16 • Number of events 11 • 1 year
|
70.6%
12/17 • Number of events 18 • 1 year
|
|
Injury, poisoning and procedural complications
Injury-Fall
|
6.2%
1/16 • Number of events 1 • 1 year
|
5.9%
1/17 • Number of events 1 • 1 year
|
|
Nervous system disorders
Peripheral Neuropathy
|
0.00%
0/16 • 1 year
|
5.9%
1/17 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Fluid Overload
|
6.2%
1/16 • Number of events 2 • 1 year
|
0.00%
0/17 • 1 year
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/16 • 1 year
|
5.9%
1/17 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.00%
0/16 • 1 year
|
5.9%
1/17 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
0.00%
0/16 • 1 year
|
5.9%
1/17 • Number of events 1 • 1 year
|
|
Vascular disorders
Access Creation
|
0.00%
0/16 • 1 year
|
17.6%
3/17 • Number of events 3 • 1 year
|
|
Vascular disorders
Access Exchange
|
6.2%
1/16 • Number of events 2 • 1 year
|
23.5%
4/17 • Number of events 9 • 1 year
|
|
Vascular disorders
Access Explant
|
12.5%
2/16 • Number of events 3 • 1 year
|
0.00%
0/17 • 1 year
|
|
Vascular disorders
Access Revision
|
6.2%
1/16 • Number of events 1 • 1 year
|
5.9%
1/17 • Number of events 1 • 1 year
|
|
Vascular disorders
Graft Swelling
|
6.2%
1/16 • Number of events 1 • 1 year
|
0.00%
0/17 • 1 year
|
|
Vascular disorders
Intervention to Restore Patency
|
75.0%
12/16 • Number of events 35 • 1 year
|
23.5%
4/17 • Number of events 5 • 1 year
|
|
Vascular disorders
Pseudoaneurysm
|
12.5%
2/16 • Number of events 2 • 1 year
|
0.00%
0/17 • 1 year
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Robert Provenzano
St John Hospital and Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place