HeRO Graft Compared to Permanent Catheters for End Stage Renal Disease (ESRD) Patients Receiving Hemodialysis
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.
End Stage Renal Disease (ESRD)
|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|
- Mortality [ Time Frame: 1 year ] [ Designated as safety issue: No ]Compare mortality rate of each study arm
- 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
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
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
After obtaining consent and enrolling in the study, participants will have the following data collected:
- Post-operative complications for patients who have had a HeRO Graft inserted.
- Length of time between insertion and use of HeRO Graft.
- Incidence of thromboses.
- Quality of life follow-up surveys at enrollment, 3 months, 6 months and 1 year.
- Incidence of infections and other non-immediate complications.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01343251
|United States, Michigan|
|St. Clair Specialty Physicians|
|Detroit, Michigan, United States, 48236|
|Principal Investigator:||Robert Provenzano, MD||St. Clair Specialty Physicians|