VectorFlow Tunneled Dialysis Catheter (TDC) Versus Palindrome TDC

Completed · Not applicable

Conditions studied: Renal Failure Chronic Requiring Hemodialysis, Chronic Renal Insufficiency

In brief

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

Key facts

Study ID: NCT02685995
Run by: University of Pennsylvania
People needed: 100
Starts: 2015-12-01
Expected to finish: 2020-07-01
Last updated by the study team: 2021-02-08

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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

Where it is running

Hospital of the Unviersity of Pennsylvania — Philadelphia, Pennsylvania, United States
Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.