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Study to Compare Palindrome vs. BioFlo DuraMax Dialysis Catheters

Primary Purpose

Chronic Kidney Disease

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bioflo Dialysis Catheter
Palindrome Dialysis Catheter
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring bioflo, Duramax catheter, dialysis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Males and females 18 - 65 years of age;
  2. First de novo dialysis catheter placement or second catheter exchange, no more than 3 replacements on a same site
  3. Requiring at least 3 months dialysis catheter usage
  4. No clinical or radiographic evidence of superior vena cava (SVC) narrowing
  5. Patent right internal or external jugular vein
  6. Willing to provide the dialysis center information for F/U
  7. No known diagnosis of hypercoagulopathy

Exclusion Criteria:

  1. Short term catheter usage plan (< 1 months)
  2. No right jugular venous access
  3. Catheter use for bone marrow transplant or plasmapheresis

Sites / Locations

  • UCLA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Bioflo Goup

Palindrome Group

Arm Description

This group will have dialysis using the Bioflo catheter.

This group will have dialysis using the Palindrome catheter.

Outcomes

Primary Outcome Measures

Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters.
A comparison of the number of tPA used as an indicator of thrombosed catheter per month between two groups

Secondary Outcome Measures

Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters.
A comparison of the number of tPA used as an indicator of thrombosed catheter per month between two groups in three month follow-up
Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters.
If necessary, we will monitor the catheter thrombosis rate of Bioflo catheters vs. Palindrome catheters.
Cost Analysis
To perform a cost-analysis and economic burden of using Bioflo catheters compared to Palindrome catheters due to catheter thrombosis and exchange.

Full Information

First Posted
May 24, 2016
Last Updated
July 30, 2020
Sponsor
University of California, Los Angeles
Collaborators
Angiodynamics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02796300
Brief Title
Study to Compare Palindrome vs. BioFlo DuraMax Dialysis Catheters
Official Title
Comparison of the Palindrome vs. BioFlo DuraMax Hemodialysis Catheters: A Prospective Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Terminated
Why Stopped
The sponsor decided to terminate the study.
Study Start Date
January 20, 2017 (Actual)
Primary Completion Date
March 27, 2019 (Actual)
Study Completion Date
June 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
Angiodynamics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Numerous catheter designs have been studied to increase efficacy and minimize complications of catheter hemodialysis. Major complications of catheters include thrombosis, central venous stenosis, infection, and dialysis inadequacy. Thrombosis must be avoided if possible because using too many catheters may exhaust all of the catheter insertion sites on the body, as well as increase the risk of infection. This prospective study compares the complications and general outcomes of patients who receive hemodialysis using the mainstream Palindrome catheter versus the newer BioFlo DuraMax catheter. This study will examine outcomes of patients who receive hemodialysis using either the Palindrome catheter or the BioFlo catheter. Patients will be observed and outcomes will be recorded for three to six months. Outcomes will be analyzed and compared to draw conclusions on which catheter produces less catheter thrombosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
bioflo, Duramax catheter, dialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bioflo Goup
Arm Type
Active Comparator
Arm Description
This group will have dialysis using the Bioflo catheter.
Arm Title
Palindrome Group
Arm Type
Active Comparator
Arm Description
This group will have dialysis using the Palindrome catheter.
Intervention Type
Device
Intervention Name(s)
Bioflo Dialysis Catheter
Intervention Description
The catheter placement procedure will be performed in the interventional radiology suite. The catheter will be inserted subcutaneously through incision in the chest through the tract.
Intervention Type
Device
Intervention Name(s)
Palindrome Dialysis Catheter
Intervention Description
The catheter placement procedure will be performed in the interventional radiology suite. The catheter will be inserted subcutaneously through incision in the chest through the tract.
Primary Outcome Measure Information:
Title
Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters.
Description
A comparison of the number of tPA used as an indicator of thrombosed catheter per month between two groups
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters.
Description
A comparison of the number of tPA used as an indicator of thrombosed catheter per month between two groups in three month follow-up
Time Frame
3 months
Title
Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters.
Description
If necessary, we will monitor the catheter thrombosis rate of Bioflo catheters vs. Palindrome catheters.
Time Frame
6 months
Title
Cost Analysis
Description
To perform a cost-analysis and economic burden of using Bioflo catheters compared to Palindrome catheters due to catheter thrombosis and exchange.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and females 18 - 65 years of age; First de novo dialysis catheter placement or second catheter exchange, no more than 3 replacements on a same site Requiring at least 3 months dialysis catheter usage No clinical or radiographic evidence of superior vena cava (SVC) narrowing Patent right internal or external jugular vein Willing to provide the dialysis center information for F/U No known diagnosis of hypercoagulopathy Exclusion Criteria: Short term catheter usage plan (< 1 months) No right jugular venous access Catheter use for bone marrow transplant or plasmapheresis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Lee, MD, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

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Study to Compare Palindrome vs. BioFlo DuraMax Dialysis Catheters

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