Study to Compare Palindrome vs. BioFlo DuraMax Dialysis Catheters

University of California, Los Angeles (UCLA) logo

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

  • Males and females 18 - 65 years of age;
  • First de novo dialysis catheter placement or second catheter exchange, no more than 3 replacements on a same site
  • Requiring at least 3 months dialysis catheter usage
  • No clinical or radiographic evidence of superior vena cava (SVC) narrowing
  • Patent right internal or external jugular vein
  • Willing to provide the dialysis center information for F/U
  • No known diagnosis of hypercoagulopathy

Exclusion criteria

  • Short term catheter usage plan (< 1 months)
  • No right jugular venous access
  • Catheter use for bone marrow transplant or plasmapheresis

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

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

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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