Study to Compare Palindrome vs. BioFlo DuraMax Dialysis Catheters

University of California, Los Angeles (UCLA)

Status: Terminated

Conditions: Chronic Kidney Disease

Treatments: Device: Palindrome Dialysis Catheter; Device: Bioflo Dialysis Catheter

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02796300

UCLA Bioflo 2016

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Bioflo Goup

Active Comparator group

Description:

This group will have dialysis using the Bioflo catheter.

Treatment:

Device: Bioflo Dialysis Catheter

Palindrome Group

Active Comparator group

Description:

This group will have dialysis using the Palindrome catheter.

Treatment:

Device: Palindrome Dialysis Catheter