HeRO Graft Compared to Permanent Catheters for End Stage Renal Disease (ESRD) Patients Receiving Hemodialysis
NCT ID: NCT01343251
Last Updated: 2017-09-08
Study Results
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View full resultsBasic Information
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COMPLETED
33 participants
OBSERVATIONAL
2011-01-31
2013-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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HeRO Graft
patients who are evaluated and receive a HeRO Graft implant for hemodialysis
No interventions assigned to this group
Control
control group of non-HeRO patients who are evaluated but do not receive a HeRO Graft for any reason
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years old
* Able to give informed consent
* Able to participate in quality of life survey
* All patients who are not candidate for arteriovenous fistula (AVF) or arteriovenous graft (AVG)
* Life expectancy 2 years or greater
* Willing and able to participate with follow-up examinations
Exclusion Criteria
* Disorder that compromises the ability to give informed consent and/or 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 the study participation
18 Years
ALL
No
Sponsors
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CryoLife, Inc.
INDUSTRY
Merit Medical Systems, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Provenzano, MD
Role: PRINCIPAL_INVESTIGATOR
St. Clair Specialty Physicians
Locations
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St. Clair Specialty Physicians
Detroit, Michigan, United States
Countries
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References
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Ethier J, Mendelssohn DC, Elder SJ, Hasegawa T, Akizawa T, Akiba T, Canaud BJ, Pisoni RL. Vascular access use and outcomes: an international perspective from the Dialysis Outcomes and Practice Patterns Study. Nephrol Dial Transplant. 2008 Oct;23(10):3219-26. doi: 10.1093/ndt/gfn261. Epub 2008 May 29.
Foley RN, Chen SC, Collins AJ. Hemodialysis access at initiation in the United States, 2005 to 2007: still "catheter first". Hemodial Int. 2009 Oct;13(4):533-42. doi: 10.1111/j.1542-4758.2009.00396.x. Epub 2009 Sep 16.
Mokrzycki MH, Zhang M, Cohen H, Golestaneh L, Laut JM, Rosenberg SO. Tunnelled haemodialysis catheter bacteraemia: risk factors for bacteraemia recurrence, infectious complications and mortality. Nephrol Dial Transplant. 2006 Apr;21(4):1024-31. doi: 10.1093/ndt/gfi104. Epub 2006 Jan 31.
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.
Hakim RM, Himmelfarb J. Hemodialysis access failure: a call to action--revisited. Kidney Int. 2009 Nov;76(10):1040-8. doi: 10.1038/ki.2009.318. Epub 2009 Aug 26.
Pisoni RL, Young EW, Dykstra DM, Greenwood RN, Hecking E, Gillespie B, Wolfe RA, Goodkin DA, Held PJ. Vascular access use in Europe and the United States: results from the DOPPS. Kidney Int. 2002 Jan;61(1):305-16. doi: 10.1046/j.1523-1755.2002.00117.x.
Surratt RS, Picus D, Hicks ME, Darcy MD, Kleinhoffer M, Jendrisak M. The importance of preoperative evaluation of the subclavian vein in dialysis access planning. AJR Am J Roentgenol. 1991 Mar;156(3):623-5. doi: 10.2214/ajr.156.3.1781814.
Bohlke M, Uliano G, Barcellos FC. Hemodialysis catheter-related infection: prophylaxis, diagnosis and treatment. J Vasc Access. 2015 Sep-Oct;16(5):347-55. doi: 10.5301/jva.5000368. Epub 2015 Apr 20.
Yoon WJ, Lorelli DR. Avoiding the use of a femoral bridging catheter using a two-stage Hemodialysis Reliable Outflow (HeRO) graft implantation technique. J Vasc Access. 2015 May-Jun;16(3):189-94. doi: 10.5301/jva.5000325. Epub 2015 Jan 20.
Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
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.
Tonnessen BH, Money SR. Embracing the fistula first national vascular access improvement initiative. J Vasc Surg. 2005 Sep;42(3):585-6. doi: 10.1016/j.jvs.2005.05.030. No abstract available.
Berwick DM, Nolan TW, Whittington J. The triple aim: care, health, and cost. Health Aff (Millwood). 2008 May-Jun;27(3):759-69. doi: 10.1377/hlthaff.27.3.759.
Dageforde LA, Bream PR, Moore DE. Hemodialysis Reliable Outflow (HeRO) device in end-stage dialysis access: a decision analysis model. J Surg Res. 2012 Sep;177(1):165-71. doi: 10.1016/j.jss.2012.04.041. Epub 2012 May 9.
Ware JE, Kosinski M, Gandek. SF-36 Health Survey Manual & Interpretation Guide. Lincoln RI, Quality Metric Incorporated, 2000, pp. 10-14
Other Identifiers
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HeRO-1
Identifier Type: -
Identifier Source: org_study_id
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