Study to Compare Palindrome vs. BioFlo DuraMax Dialysis Catheters

Not Applicable

Terminated

• Conditions: Chronic Kidney Disease
• Interventions: Device: Palindrome Dialysis Catheter; Device: Bioflo Dialysis Catheter

• Registration Number: NCT02796300
• Lead Sponsor: University of California, Los Angeles

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-24
• Study First Submitted QC: 2016-06-09
• Study First Posted: 2016-06-10
• Study Start: 2017-01-20
• Primary Completion: 2019-03-27
• Study Completion: 2019-06-25
• Results First Submitted: 2020-03-26
• Results First Submitted QC: 2020-03-26
• Results First Posted: 2020-04-13
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-30
• Last Update Posted: 2020-08-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 32

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Palindrome Group	Palindrome Dialysis Catheter	This group will have dialysis using the Palindrome catheter.
Bioflo Goup	Bioflo Dialysis Catheter	This group will have dialysis using the Bioflo catheter.

Primary Outcome Measures

Name	Time	Method
Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters.	1 month	A comparison of the number of tPA used as an indicator of thrombosed catheter per month between two groups

Secondary Outcome Measures

Name	Time	Method
Cost Analysis	3 months	To perform a cost-analysis and economic burden of using Bioflo catheters compared to Palindrome catheters due to catheter thrombosis and exchange.
Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters.	6 months	If necessary, we will monitor the catheter thrombosis rate of Bioflo catheters vs. Palindrome catheters.

Trial Locations

Locations (1)

UCLA Medical Center; 🇺🇸 Los Angeles, California, United States