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Completed

NCT Number: NCT02685995

VectorFlow Tunneled Dialysis Catheter (TDC) Versus Palindrome TDC

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

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Key information

Conditions

Renal Failure Chronic Requiring Hemodialysis Chronic Disease Chronic Renal Insufficiency Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of the Unviersity of Pennsylvania, Philadelphia, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VectorFlow TDC

Device

TDC insertion with VectorFlow will be in accordance with its FDA-approved indication under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per institutional protocol. Following TDC insertion, the catheter may be used immediately. The goal of HD is typically to achieve a target effective blood flow of 300mL/min within the first 3 hemodialysis sessions. The dialysis records from each of the first three HD sessions will be reviewed by the study coordinator for (A) Blood flow rate (QB), (B) Arterial and venous lumen pressures, (C) Kt/V, and (D) Urea reduction ratio (URR). Additionally, need and use of thrombolytic infusion (ie t-PA) (other than single dose injection) to restore or improve patency and/or need for catheter exchange.

Other names: ARROW-Clark™ VectorFlow™ Hemodialysis Catheter

Palindrome TDC

Device

TDC insertion with Palindrome will be in accordance with its FDA-approved indication under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per institutional protocol. Following TDC insertion, the catheter may be used immediately. The goal of HD is typically to achieve a target effective blood flow of 300mL/min within the first 3 hemodialysis sessions. The dialysis records from each of the first three HD sessions will be reviewed by the study coordinator for (A) Blood flow rate (QB), (B) Arterial and venous lumen pressures, (C) Kt/V, and (D) Urea reduction ratio (URR). Additionally, need and use of thrombolytic infusion (ie t-PA) (other than single dose injection) to restore or improve patency and/or need for catheter exchange.

Other names: Palindrome™ Dialysis Catheter

Primary outcomes

  1. Primary Patency - Intervention-free Interval (Measured in Weeks)

    Time frame: 30, 60 and 90 days

    The primary study endpoint will be primary patency at 90 days following catheter insertion. Primary patency is defined as an HD catheter which provides adequate hemodialysis (flow >300mL/min) without need for additional interventions (ie TPA infusions or catheter exchange) to maintain flow or correct device failure.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Arrow International
  • Teleflex

Registry information

Official study title

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

Acronym: TDC

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
Feb 19, 2016
Registry last updated
Feb 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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