Study to Compare Palindrome vs. BioFlo DuraMax Dialysis Catheters

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02796300
• Other study ID #: UCLA Bioflo 2016
• Status: Terminated
• Phase: N/A
• Start date: January 20, 2017
• Est. completion date: June 25, 2019

Study information

• Verified date: July 2020
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: June 25, 2019
• Est. primary completion date: March 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	UCLA Medical Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	Angiodynamics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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