VectorFlow Tunneled Dialysis Catheter (TDC) Versus Palindrome TDC



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - 80
Updated:11/16/2018
Start Date:December 2015
End Date:December 2019
Contact:Kristine Lima, BS
Email:kristine.lima@uphs.upenn.edu
Phone:215-898-0190

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Randomized Trial Comparing VectorFlow Tunneled Dialysis Catheter to Palindrome Tunneled Dialysis Catheter

Randomized two-arm study examining 90 day primary patency of two FDA-approved tunneled
dialysis catheters.

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.

Inclusion Criteria:

- End stage renal disease or acute renal failure requiring hemodialysis through a
tunneled dialysis catheter

- Age >18, Age <80

- Capable of giving informed consent

Exclusion Criteria:

- 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
We found this trial at
2
sites
Philadelphia, Pennsylvania 19104
Principal Investigator: Gregory Nadolski, MD
Phone: 215-898-0190
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Philadelphia, Pennsylvania
Principal Investigator: Gregory Nadolski, MD
Phone: 215-898-0190
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials