N/A
N=100
VectorFlow Tunneled Dialysis Catheter (TDC) Versus Palindrome TDC
Renal Failure Chronic Requiring Hemodialysis · Chronic Renal Insufficiency
Bottom Line
View on ClinicalTrials.gov: NCT02685995 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Primary Patency - Intervention-free Interval (Measured in Weeks) — 89.1; 95.5; 79.4; 87.2 percentage of primary patency
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- VectorFlow TDC (Device); Palindrome TDC (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Patency - Intervention-free Interval (Measured in Weeks) |
89.1; 95.5; 79.4; 87.2; 71.5; 80.6 | — |
Summary
Randomized two-arm study examining 90 day primary patency of two FDA-approved tunneled dialysis catheters.
Eligibility Criteria
Inclusion Criteria
- End stage renal disease or acute renal failure requiring hemodialysis through a tunneled dialysis catheter
- Age >18, Age 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
Data sourced from ClinicalTrials.gov (NCT02685995). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.