Dialysis Catheter Comparative Clinical Trial

Completed · Not applicable

Conditions studied: End Stage Renal Disease

In brief

The purpose of this clinical trial is to compare the longevity of two dialysis catheters.

Key facts

Study ID

NCT00526123

Run by

Tyco Healthcare Group

People needed

599

Starts

2007-09-01

Expected to finish

2011-08-01

Last updated by the study team

2013-01-07

Who can join

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

You may qualify if…

• Subject must be 18 years of age or older.
• Subject must meet labeled indication for hemodialysis.
• Subject must have End Stage Renal Disease (ESRD).
• Subject must have a patent right or left internal jugular vein.
• Subject treatment plan must require chronic hemodialysis treatments 3 times per week for a minimum of 6 weeks.
• Subject must give written informed consent.

You may not qualify if…

• Subjects who are concurrently enrolled in any Randomized Clinical Trial (RCT) or those that may enroll in a RCT during the course of the study, or subjects who have been previously randomized into this clinical study.
• Subjects with active infection at the time of study enrollment.
• Subjects with a known sensitivity to heparin, or previous incidence of heparin-induced thrombocytopenia.
• Subjects with uncontrolled abnormal coagulation parameters and are at additional risk for clotting or excessive bleeding.
• Subjects who are known or suspected to be pregnant at the time of study enrollment or plan to get pregnant during the study period.
• Subjects for whom performing dialysis at flow rates up to 450 mL/min would be contraindicated for any reason.
• Subject unable or unwilling to commit to follow-up visits and study procedures throughout the course of the study.
• Subjects who, in the opinion of the Investigators, are not appropriate candidates for the study based upon current or past medical history, or negative past experience with either of the study catheters.

Where it is running

• Nephrology Associates, P.C. — Birmingham, Alabama, United States
• Southwest Kidney Institute — Phoenix, Arizona, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• SUNY Stony Brook Medical Center — Stony Brook, New York, United States
• Eastern Nephrology Associates — Greenville, North Carolina, United States
• Eastern Nephrology Associates — New Bern, North Carolina, United States
• Boice-Willis Clinic — Rocky Mount, North Carolina, United States
• Dialysis Access Group of Wake Forest University, LLC — Winston-Salem, North Carolina, United States
• Toledo Hospital — Toledo, Ohio, United States
• Temple University Hospital — Philadelphia, Pennsylvania, United States
• Nephrology Associates - Lankenau Hospital — Wynnewood, Pennsylvania, United States
• Columbia Nephrology Associates — Columbia, South Carolina, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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