Study to Compare Palindrome vs. BioFlo DuraMax Dialysis Catheters

July 30, 2020 updated by: Edward Wolfgang Lee, MD, University of California, Los Angeles

Comparison of the Palindrome vs. BioFlo DuraMax Hemodialysis Catheters: A Prospective Randomized Trial

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bioflo Goup
This group will have dialysis using the Bioflo catheter.
Device: Bioflo Dialysis Catheter
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.
Active Comparator: Palindrome Group
This group will have dialysis using the Palindrome catheter.
Device: Palindrome Dialysis Catheter
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters.
Time Frame: 1 month
A comparison of the number of tPA used as an indicator of thrombosed catheter per month between two groups
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters.
Time Frame: 3 months
A comparison of the number of tPA used as an indicator of thrombosed catheter per month between two groups in three month follow-up
3 months
Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters.
Time Frame: 6 months
If necessary, we will monitor the catheter thrombosis rate of Bioflo catheters vs. Palindrome catheters.
6 months
Cost Analysis
Time Frame: 3 months
To perform a cost-analysis and economic burden of using Bioflo catheters compared to Palindrome catheters due to catheter thrombosis and exchange.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

Angiodynamics, Inc.

Investigators

  • Principal Investigator: Edward Lee, MD, PhD, University of California, Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2017

Primary Completion (Actual)

March 27, 2019

Study Completion (Actual)

June 25, 2019

Study Registration Dates

First Submitted

May 24, 2016

First Submitted That Met QC Criteria

June 9, 2016

First Posted (Estimate)

June 10, 2016

Study Record Updates

Last Update Posted (Actual)

August 13, 2020

Last Update Submitted That Met QC Criteria

July 30, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCLA Bioflo 2016

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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