Study to Compare Palindrome vs. BioFlo DuraMax Dialysis Catheters
| Status: | Recruiting |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 5/10/2018 |
| Start Date: | January 20, 2017 |
| End Date: | June 2019 |
| Contact: | Victoria Rueda, MPH |
| Email: | VRueda@mednet.ucla.edu |
| Phone: | 310-794-8334 |
Comparison of the Palindrome vs. BioFlo DuraMax Hemodialysis Catheters: A Prospective Randomized Trial
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.
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.
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
We found this trial at
1
site
757 Westwood Plaza
Los Angeles, California 90024
Los Angeles, California 90024
(310) 825-9111
Phone: 310-794-8334
UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
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