N/A
Completed N=100
VectorFlow Tunneled Dialysis Catheter (TDC) Versus Palindrome TDC
Renal Failure Chronic Requiring Hemodialysis · Chronic Renal Insufficiency
Source: ClinicalTrials.gov NCT02685995 ↗
Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcomePrimary: Primary Patency - Intervention-free Interval (Measured in Weeks) — 89.1; 95.5; 79.4; 87.2 percentage of primary patency
Summary
Randomized two-arm study examining 90 day primary patency of two FDA-approved tunneled dialysis catheters.
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 | — |
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. Informational only — not medical advice.