An observational study in End Stage Renal Disease (ESRD), sponsored by Merit Medical Systems, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-08.
Sponsored by Merit Medical Systems, Inc. · Observational
The main objective of this research study was to compare the following outcomes between patients with a Hemodialysis Reliable Outflow (HeRO) Graft and patients with a cuffed catheter for dialysis access over one year: quality of life and incidence of bacteremia, vascular interventions, hospitalizations, and death.
All eligible participants who provided informed consent were included in the study. Participants who refused HeRO Graft implantation, or did not have the HeRO Graft implanted for any other reason, were followed in the control group. Several patients did not receive the HeRO graft due to anatomical challenges and failure to complete both steps of the two-stage implant procedure. All consented participants who had an implanted HeRO Graft were followed in the study group. All participants were followed until the study end, withdrawal, loss to follow-up, or death. The analysis included only HeRO Graft patients and control patients who were not lost to follow-up; patients who were lost to follow-up, before data collection, were excluded from analysis.
After obtaining Institutional Review Board (IRB) approval, baseline demographic and clinical data was collected. Following surgery, implant procedure data was collected on study participants who received HeRO Grafts. HeRO Grafts were placed using a 2-step process with initial placement of the ePTFE portion, followed by completion of the graft by placement of the venous outflow component. Following enrollment, outcomes of interest were collected at follow-up visits scheduled weekly for 4 weeks, bi-weekly for 3 months, and monthly to 1 year, for a total of 18 follow-up visits. Study coordinators documented post-operative complications, incidence of thrombosis, hospitalizations, infection incidents, and deaths at each follow-up.
Quality of life data were also collected from all participants using the RAND Corporation's Short Form (36) (SF-36) Health Survey. This survey was completed at enrollment and again at 3 months, 6 months, and 12 months.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 33 is below the median of 192 across 1,033 observational studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Merit Medical Systems, Inc. is the lead sponsor of 28 studies on the registry; 4 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
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Participants with ESRD requiring permanent cuffed catheters were targeted. Participants who had not exhausted peripheral venous access sites suitable for fistulas and grafts were excluded.
Exclusion Criteria:
patients who are evaluated and receive a HeRO Graft implant for hemodialysis
control group of non-HeRO patients who are evaluated but do not receive a HeRO Graft for any reason
Mortality
Compare mortality rate between study arms
Time frame: 1 year
Infection Rate (Percentage of Participants With at Least One Infection)
Compare incidence of infection between study arms
Time frame: 1 year
Quality of Life
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).
Time frame: 1 year
Intervention Rate (Percentage of Participants Who Required at Least One Intervention While on Study)
Compare 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.
Time frame: 1 year
Hospitalization Rate (Percentage of Participants Who Were Hospitalized at Least Once While on Study)
Compare 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.
Time frame: 1 year
| Milestone | HeRO Graft | Control |
|---|---|---|
| Started | 16 | 17 |
| Completed | 16 | 17 |
| Not completed | 0 | 0 |
Compare mortality rate between study arms
| percentage of participants who died | HeRO Graft | Control |
|---|---|---|
| Mortality | 18.8 | 29.4 |
Compare incidence of infection between study arms
| Percentage of Patients | HeRO Graft | Control |
|---|---|---|
| Infection Rate (Percentage of Participants With at Least One Infection) | 25.0 | 64.7 |
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).
| units on a scale | HeRO Graft | Control |
|---|---|---|
| Test 1 (Baseline) | 58.06 ± 25.49 | 51.30 ± 28.78 |
| Test 2 (3 Months) | 56.30 ± 23.78 | 55.22 ± 22.40 |
| Test 3 (6 Months) | 58.44 ± 22.08 | 53.53 ± 23.49 |
| Test 4 (12 Months) | 60.41 ± 18.06 | 20.14 ± 4.67 |
Compare 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.
| percentage of participants | HeRO Graft | Control |
|---|---|---|
| Intervention Rate (Percentage of Participants Who Required at Least One Intervention While on Study) | 93.8 | 64.7 |
Compare 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.
| Percentage of patients | HeRO Graft | Control |
|---|---|---|
| Hospitalization Rate (Percentage of Participants Who Were Hospitalized at Least Once While on Study) | 62.5 | 64.7 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HeRO Graft | — | 16/16 (100%) | 0/16 (0%) |
| Control | — | 15/17 (88.2%) | 0/17 (0%) |
| Event | HeRO Graft | Control |
|---|---|---|
| Intervention to Restore PatencyVascular disorders | 12/16 | 4/17 |
| InfectionInfections and infestations | 6/16 | 12/17 |
| Access ExchangeVascular disorders | 1/16 | 4/17 |
| Death-Unknown CauseGeneral disorders | 3/16 | 3/17 |
| Access CreationVascular disorders | 0/16 | 3/17 |
| BleedingBlood and lymphatic system disorders | 2/16 | 0/17 |
| Access ExplantVascular disorders | 2/16 | 0/17 |
| PseudoaneurysmVascular disorders | 2/16 | 0/17 |
| Congestive Heart FailureCardiac disorders | 0/16 | 2/17 |
| Pulmonary EmbolismBlood and lymphatic system disorders | 1/16 | 0/17 |
| Age, Continuous(years) | HeRO Graft | Control | Total |
|---|---|---|---|
| Mean | 56.69 ± 11.08 | 63.12 ± 11.49 | 60.00 ± 11.38 |
| Sex: Female, Male(Participants) | HeRO Graft | Control | Total |
|---|---|---|---|
| Female | 9 | 12 | 21 |
| Male | 7 | 5 | 12 |
| Region of Enrollment(participants) | HeRO Graft | Control | Total |
|---|---|---|---|
| United States | 16 | 17 | 33 |
Plan to share: No
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Merit Medical Systems, Inc.