Study to Compare Palindrome vs. BioFlo DuraMax Dialysis Catheters

• ClinicalTrials.gov Identifier: NCT02796300
• Recruitment Status: Terminated
• First Posted: June 10, 2016
• Results First Posted: April 13, 2020
• Last Update Posted: August 13, 2020
• Sponsor: University of California, Los Angeles
• Collaborator: Angiodynamics, Inc.
• Information provided by (Responsible Party): Edward Wolfgang Lee, MD, University of California, Los Angeles

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.

Condition or disease	Intervention/treatment	Phase
Chronic Kidney Disease	Device: Bioflo Dialysis Catheter; Device: Palindrome Dialysis Catheter	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparison of the Palindrome vs. BioFlo DuraMax Hemodialysis Catheters: A Prospective Randomized Trial
• Actual Study Start Date: January 20, 2017
• Actual Primary Completion Date: March 27, 2019
• Actual Study Completion Date: June 25, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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
2. 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.
3. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, California

UCLA Medical Center

Los Angeles, California, United States, 90095

Sponsors and Collaborators

University of California, Los Angeles

Angiodynamics, Inc.

Investigators

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

  Study Documents (Full-Text)

Documents provided by Edward Wolfgang Lee, MD, University of California, Los Angeles:

Study Protocol and Statistical Analysis Plan  [PDF] August 3, 2016

Informed Consent Form  [PDF] February 21, 2018

More Information

• Responsible Party: Edward Wolfgang Lee, MD, MD, PhD, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT02796300
• Other Study ID Numbers: UCLA Bioflo 2016
• First Posted: June 10, 2016
• Results First Posted: April 13, 2020
• Last Update Posted: August 13, 2020
• Last Verified: July 2020

• 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

Keywords provided by Edward Wolfgang Lee, MD, University of California, Los Angeles:

bioflo; Duramax catheter; dialysis

Additional relevant MeSH terms:

Kidney Diseases; Renal Insufficiency, Chronic; Urologic Diseases; Renal Insufficiency