Study Results
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View full resultsBasic Information
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COMPLETED
NA
599 participants
INTERVENTIONAL
2007-09-30
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
symmetric tip catheter
Symmetric Tip Catheter
Dialysis catheter
2
conventional split-tip catheter
Conventional Split-tip Catheter
Dialysis Catheter
Interventions
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Symmetric Tip Catheter
Dialysis catheter
Conventional Split-tip Catheter
Dialysis Catheter
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Tyco Healthcare Group
INDUSTRY
Responsible Party
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Principal Investigators
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Klemens B Meyer, MD
Role: PRINCIPAL_INVESTIGATOR
Locations
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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
Countries
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Other Identifiers
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341.26
Identifier Type: -
Identifier Source: org_study_id
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