Data Collection Registry of the HeRO Graft for End Stage Renal Disease Patients Receiving Hemodialysis
Study Details
Study Description
Brief Summary
Data Collection Registry of the HeRO Graft for End Stage Renal Disease Patients Receiving Hemodialysis
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Data collection including medical history, operative procedure data, and follow-up data every six months while using the HeRO Graft for dialysis, including:
-
Post-operative complications for HeRO Graft implantation
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Length of time between insertion and use of HeRO Graft
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Incidence of thrombosis
-
Hospitalizations
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Incidence of infections and other adverse event occurrence
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Mortality
-
Hemoglobin
-
Kt/V
-
pre-dialysis blood pressure
-
post-dialysis blood pressure
-
blood flow rate and
-
dialysis flow rate
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| HeRO Graft End stage renal disease patients who receive HeRO Graft implant for dialysis access |
Device: HeRO Graft implant for dialysis access
End Stage Renal Disease patients who receive HeRO Graft implant for dialysis access
|
Outcome Measures
Primary Outcome Measures
- Mortality [Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years]
To evaluate if the death rate of participants using the HeRO Graft is less than the death rate of patients who do not receive the HeRO Graft and continue to use a tunneled dialysis catheter for dialysis.
Secondary Outcome Measures
- Adequacy of dialysis (Kt/V) [Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years]
To evaluate if the adequacy of dialysis of participants using the HeRO Graft is better than the adequacy of dialysis of patients who do not receive the HeRO Graft and continue to use a tunneled dialysis catheter for dialysis.
- Infection rate [Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years]
To evaluate if the infection rate of participants using the HeRO Graft is less than the infection rate of patients who do not receive the HeRO Graft and continue to use a tunneled dialysis catheter for dialysis.
Other Outcome Measures
- Hospitalization rate [Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years]
To evaluate if the hospitalization rate of participants using the HeRO Graft is less than that of patients who do not receive the HeRO Graft and continue to use a tunneled dialysis catheter for dialysis.
- Patency rate [Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years]
To evaluate if the patency rate of participants using the HeRO Graft is less than that of patients who do not receive the HeRO Graft and continue to use a tunneled dialysis catheter for dialysis.
- Intervention rate [Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years]
To evaluate if the intervention rate of participants using the HeRO Graft is less than that of patients who do not receive the HeRO Graft and continue to use a tunneled dialysis catheter for dialysis.
- Adverse events [Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years]
To evaluate if the number of adverse events of participants using the HeRO Graft is less than that of patients who do not receive the HeRO Graft and continue to use a tunneled dialysis catheter for dialysis.
- Blood pressure [Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years]
To evaluate if the blood pressure of participants using the HeRO Graft is less than that of patients who do not receive the HeRO Graft and continue to use a tunneled dialysis catheter for dialysis.
Eligibility Criteria
Criteria
Inclusion Criteria:
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All patients eligible for HeRO Graft for dialysis access
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Age greater than 18 years old
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Able to give informed consent
Exclusion Criteria:
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Subjects with any kind of disorder that compromises the ability of the subject to give informed consent and/or to comply with the study procedures;
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Any medical condition that in the opinion of the investigator may pose a safety risk to a subject in the study or which may interfere with study participation.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
| 2 | Baylor Research Institute | Dallas | Texas | United States | 75246 |
| 3 | Sentara Medical Group Sentara Vascular Specialists | Norfolk | Virginia | United States | 23507 |
Sponsors and Collaborators
- Merit Medical Systems, Inc.
- CryoLife, Inc.
Investigators
- Principal Investigator: Jeffrey Lawson, MD, Duke University
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Gage SM, Katzman HE, Ross JR, Hohmann SE, Sharpe CA, Butterly DW, Lawson JH. Multi-center experience of 164 consecutive Hemodialysis Reliable Outflow [HeRO] graft implants for hemodialysis treatment. Eur J Vasc Endovasc Surg. 2012 Jul;44(1):93-9. doi: 10.1016/j.ejvs.2012.04.011. Epub 2012 May 12.
- Katzman HE, McLafferty RB, Ross JR, Glickman MH, Peden EK, Lawson JH. Initial experience and outcome of a new hemodialysis access device for catheter-dependent patients. J Vasc Surg. 2009 Sep;50(3):600-7, 607.e1. doi: 10.1016/j.jvs.2009.04.014. Epub 2009 Jul 22.
- Nassar GM, Glickman MH, McLafferty RB, Croston JK, Zarge JI, Katzman HE, Peden EK, Lawson JH, Martinez JM, Thackeray L. A comparison between the HeRO graft and conventional arteriovenous grafts in hemodialysis patients. Semin Dial. 2014 May-Jun;27(3):310-8. doi: 10.1111/sdi.12173. Epub 2014 Jan 15.
- HRG1301.000-M