Clinical trial NCT02685995: VectorFlow Tunneled Dialysis Catheter (TDC) Versus Palindrome TDC
Official title: Randomized Trial Comparing VectorFlow Tunneled Dialysis Catheter to Palindrome Tunneled Dialysis Catheter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Failure Chronic Requiring Hemodialysis
Chronic Renal Insufficiency
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Teleflex
name: Arrow International
First posted: 2016-02-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary Patency - Intervention-free Interval (Measured in Weeks)
timeFrame: 30, 60 and 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the Unviersity of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Gregory Nadolski, MD
role: PRINCIPAL_INVESTIGATOR
References: