NCT00526123CompletedNot Applicable
A Randomized, Open-label Comparison of the Performance and Longevity of a Split-tip Versus a Symmetric Tip Hemodialysis
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tyco Healthcare Group
- Enrollment
- 599
- Locations
- 27
- Primary Endpoint
- First Catheter Induced Complication
Study Overview
Brief Summary
The purpose of this clinical trial is to compare the longevity of two dialysis catheters.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
First Catheter Induced Complication
Time Frame: 245 days
% of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.
Secondary Outcomes
- Inadequate Flow Rates Requiring Surgical/Radiological Intervention(35 weeks)
- Average Number of Line Reversals Per Subject(35 Weeks)
- Frequency of Clinician Interventions for Catheter Malfunction and Infection(35 Weeks)
- Primary Failure Rate(First dialysis session with study catheter)
- Reliability of the Catheter(35 Weeks)
Investigators
Study Sites (27)
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