Study to Compare Palindrome vs. BioFlo DuraMax Dialysis Catheters

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: Chronic Kidney Disease
• Intervention / Treatment: Device: Bioflo Dialysis Catheter; Device: Palindrome Dialysis Catheter

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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.	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.	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.	If necessary, we will monitor the catheter thrombosis rate of Bioflo catheters vs. Palindrome catheters.	6 months
Cost Analysis	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

• Sponsor: University of California, Los Angeles
• Collaborators: Angiodynamics, Inc.
• Investigators: Principal Investigator: Edward Lee, MD, PhD, University of California, Los Angeles

Study record dates

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: dialysis; bioflo; Duramax catheter
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• 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