Study to Compare Palindrome vs. BioFlo DuraMax Dialysis Catheters

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Device: Bioflo Dialysis Catheter
* Device: Palindrome Dialysis Catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bioflo Goup<br>This group will have dialysis using the Bioflo catheter. | Device: Bioflo Dialysis Catheter<br>* 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.<br>|
| Active Comparator: Palindrome Group<br>This group will have dialysis using the Palindrome catheter. | Device: Palindrome Dialysis Catheter<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bioflo, Duramax catheter, dialysis