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HeRO Graft Compared to Permanent Catheters for End Stage Renal Disease (ESRD) Patients Receiving Hemodialysis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Hemosphere, Inc..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hemosphere, Inc.
ClinicalTrials.gov Identifier:
NCT01343251
First received: April 20, 2011
Last updated: April 27, 2011
Last verified: April 2011
History of Changes
  Purpose

The main goal of this research study is to see if the use of HeRO grafts in dialysis patients will decrease the rate of infections, decrease hospitalizations, and improve quality of life compared to the use of semi-permanent catheters for dialysis.


Condition
End Stage Renal Disease (ESRD)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Prospective Observational Study to Determine if HeRO Graft Devices Are Non-inferior to Arteriovenous Grafts and Permanent Catheters in End Stage Renal Disease Subjects Receiving Dialysis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hemosphere, Inc.:

Primary Outcome Measures:
  • Mortality [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Compare mortality rate of each study arm


Secondary Outcome Measures:
  • Adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Compare incidence of adverse events in each study arm

  • Infection rate [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Compare incidence of infection in each study arm, as evidenced by symptoms requiring treatment with antibiotics or culture results

  • Quality of Life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Compare Quality of Life (QOL) changes in each study arm, assessed with SF36 QOL survey collected at baseline, 3 months, 6 months, and 1 year

  • Patency [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Compare incidence of thrombosis in each study arm as evidenced by intervention rates

  • Hospitalization rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Compare incidence of hospitalization for any reason in each study arm


Estimated Enrollment: 75
Study Start Date: January 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
HeRO graft
patients who are evaluated and receive a 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

Detailed Description:

After obtaining consent and enrolling in the study, participants will have the following data collected:

  1. Post-operative complications for patients who have had a HeRO Graft inserted.
  2. Length of time between insertion and use of HeRO Graft.
  3. Incidence of thromboses.
  4. Hospitalizations.
  5. Quality of life follow-up surveys at enrollment, 3 months, 6 months and 1 year.
  6. Incidence of infections and other non-immediate complications.
  7. Mortality.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

dialysis units

Criteria

Inclusion Criteria:

  • ESRD patients requiring hemodialysis
  • Age > 18 years old
  • Able to give informed consent
  • Able to participate in quality of life survey
  • All patients who are not candidate for AVF or AVG
  • Life expectancy 2 years or greater
  • Willing and able to participate with follow-up examinations

Exclusion Criteria:

  • Pregnant or breastfeeding females
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01343251

Contacts
Contact: Paula LaFleur, RN 313-866-8787 paula.lafleur@stjohn.org
Contact: Robert Provenzano, MD 313-866-8787 rprovenzano@scsp.net

Locations
United States, Michigan
St. Clair Specialty Physicians Recruiting
Detroit, Michigan, United States, 48236
Principal Investigator: Robert Provenzano, MD            
Sponsors and Collaborators
Hemosphere, Inc.
Investigators
Principal Investigator: Robert Provenzano, MD St. Clair Specialty Physicians
  More Information

Publications:

Responsible Party: Robert Provenzano, MD, St. Clair Specialty Physicians
ClinicalTrials.gov Identifier: NCT01343251     History of Changes
Other Study ID Numbers: HeRO-1
Study First Received: April 20, 2011
Last Updated: April 27, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Hemosphere, Inc.:
dialysis
HeRO graft
catheter

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on May 16, 2013