Dialysis Catheter Comparative Clinical Trial

Tyco Healthcare Group

Status

Completed

Conditions

End Stage Renal Disease

Treatments

Device: Conventional Split-tip Catheter

Device: Symmetric Tip Catheter

Study type

Interventional

Funder types

Industry

Identifiers

NCT00526123

341.26

Details and patient eligibility

About

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

Full description

This study is a multi-center, randomized, prospective, open-label, clinical study comparing a conventional split-tip catheter and a symmetric tip catheter in subjects undergoing hemodialysis.

Enrollment

599 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.