This trial is active, not recruiting.

Condition end stage renal disease (esrd)
Sponsor Hemosphere, Inc.
Collaborator CryoLife, Inc.
Start date January 2011
End date December 2013
Trial size 75 participants
Trial identifier NCT01343251, HeRO-1


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
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

Primary Outcomes

time frame: 1 year

Secondary Outcomes

Adverse events
time frame: 1 year
Infection rate
time frame: 1 year
Quality of Life
time frame: 1 year
time frame: 1 year
Hospitalization rate
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Robert Provenzano, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2013.
Information provided to ClinicalTrials.gov by Hemosphere, Inc..