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Keep this study
Lead
University of Pennsylvania
With
Teleflex
Arrow International
The VectorFlow tunneled dialysis catheter is a novel symmetrical tip design tunneled dialysis catheter which in pre-clinical testing and retrospective review has improved flow and patency compared to other dialysis catheter designs. This study will compare 90 day patency rates of newly inserted VF catheters to the Palindrome catheter both of which are FDA approved devices and will inserted as standard of care. The Palindrome catheter has been selected as the comparison device because it is also a symmetrical tip catheter design and prior studies by the manufacturer of this device suggests it has a lower occlusion rate and better flow compared to other catheter designs.
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
End stage renal disease or acute renal failure requiring hemodialysis through a tunneled dialysis catheter
Age \>18, Age \<80
Capable of giving informed consent
You may not be if
Coagulopathy defined as international normalized ration (INR) \>2 which cannot be corrected with fresh frozen plasma
Platelet count \<50,000/microliter, which cannot be corrected with platelet transfusion
Active skin infections at site of TDC insertion
Presence of bacteremia or infected AVG/AVF within 7 days prior to enrollment
Neutropenia defined as absolute neutrophil count less then 1,700/microliter
Known central venous stenosis
Occlusion of bilateral external and internal jugular veins or bilateral brachiocephalic veins or stenosis of the superior vena cava
Functioning surgical HD access (ie AVG/AVF) or AVG/AVF which is expected to be functional within 90 days of enrollment
Inability to provide informed consent
Pregnant or nursing women
In the event a physician does not feel that either catheter would be appropriate for a subject, the subject will not be eligible to participate