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

Completed

Conditions studied: End Stage Renal Disease (ESRD)

In brief

The main objective of this research study was to compare the following outcomes between patients with a Hemodialysis Reliable Outflow (HeRO) Graft and patients with a cuffed catheter for dialysis access over one year: quality of life and incidence of bacteremia, vascular interventions, hospitalizations, and death.

Key facts

Study ID

NCT01343251

Run by

Merit Medical Systems, Inc.

People needed

33

Starts

2011-01-01

Expected to finish

2013-12-01

Last updated by the study team

2017-09-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 arteriovenous fistula (AVF) or arteriovenous graft (AVG)
• Life expectancy 2 years or greater
• Willing and able to participate with follow-up examinations

You may not qualify if…

• 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

Where it is running

• St. Clair Specialty Physicians — Detroit, Michigan, United States

Full record on ClinicalTrials.gov

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