search
Back to results

VectorFlow Tunneled Dialysis Catheter (TDC) Versus Palindrome TDC (TDC)

Primary Purpose

Renal Failure Chronic Requiring Hemodialysis, Chronic Renal Insufficiency

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VectorFlow TDC
Palindrome TDC
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Failure Chronic Requiring Hemodialysis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital of the Unviersity of Pennsylvania
  • Penn Presbyterian Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Palindrome TDC

VectorFlow TDC

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 15, 2016
Last Updated
January 20, 2021
Sponsor
University of Pennsylvania
Collaborators
Teleflex, Arrow International
search

1. Study Identification

Unique Protocol Identification Number
NCT02685995
Brief Title
VectorFlow Tunneled Dialysis Catheter (TDC) Versus Palindrome TDC
Acronym
TDC
Official Title
Randomized Trial Comparing VectorFlow Tunneled Dialysis Catheter to Palindrome Tunneled Dialysis Catheter
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
July 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Teleflex, Arrow International

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure Chronic Requiring Hemodialysis, Chronic Renal Insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Palindrome TDC
Arm Type
Active Comparator
Arm Description
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.
Arm Title
VectorFlow TDC
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
VectorFlow TDC
Other Intervention Name(s)
ARROW-Clark™ VectorFlow™ Hemodialysis Catheter
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Palindrome TDC
Other Intervention Name(s)
Palindrome™ Dialysis Catheter
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary Patency - Intervention-free Interval (Measured in Weeks)
Description
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.
Time Frame
30, 60 and 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Nadolski, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of the Unviersity of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Penn Presbyterian Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.teleflex.com/en/usa/productAreas/interventionalAccess/productGroups/chronic-hemodialysis/products/vector/
Description
Vectorlow Dialysis Catheter Product Information

Learn more about this trial

VectorFlow Tunneled Dialysis Catheter (TDC) Versus Palindrome TDC

We'll reach out to this number within 24 hrs