Clinical trial NCT02164175: Data Collection Registry of the HeRO Graft for End Stage Renal Disease Patients Receiving Hemodialysis
Official title: Data Collection Registry of the HeRO Graft for End Stage Renal Disease Patients Receiving Hemodialysis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: End Stage Renal Failure on Dialysis
Keywords: HeRO Graft
Lead sponsor: Merit Medical Systems, Inc.
Sponsor class: INDUSTRY
Collaborators: name: CryoLife, Inc.
First posted: 2014-06-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients eligible for HeRO Graft for dialysis access

Brief summary: Data Collection Registry of the HeRO Graft for End Stage Renal Disease Patients Receiving Hemodialysis

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
* Length of time between insertion and use of HeRO Graft
* Incidence of thrombosis
* Hospitalizations
* Incidence of infections and other adverse event occurrence
* Mortality
* Hemoglobin
* Kt/V
* pre-dialysis blood pressure
* post-dialysis blood pressure
* blood flow rate and
* dialysis flow rate

Eligibility criteria: Inclusion Criteria:

* All patients eligible for HeRO Graft for dialysis access
* Age greater than 18 years old
* Able to give informed consent

Exclusion Criteria:

* 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;
* 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.

Primary outcomes:
measure: Mortality
timeFrame: Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years
Secondary outcomes:
measure: Adequacy of dialysis (Kt/V)
timeFrame: Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years
measure: Infection rate
timeFrame: Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years
Other outcomes:
measure: Hospitalization rate
timeFrame: Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years
measure: Patency rate
timeFrame: Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years
measure: Intervention rate
timeFrame: Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years
measure: Adverse events
timeFrame: Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years
measure: Blood pressure
timeFrame: Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Dallas
country: United States
facility: Baylor Research Institute
state: Texas
city: Norfolk
country: United States
facility: Sentara Medical Group Sentara Vascular Specialists
state: Virginia
Study officials:
affiliation: Duke University
name: Jeffrey Lawson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.