Comparison of the Palindrome vs. BioFlo DuraMax Hemodialysis Catheters: A Prospective Randomized Trial
Phase: NA
Conditions: Chronic Kidney Disease
Sponsor: University of California, Los Angeles

 
 
 
Research Study Proposal v4 
 
ClinicalTrials.gov# : 
NCT02796300 
 
Study Title:   
 
Study to Compare Palindrome vs. BioFlo DuraMax  
Dialysis Catheters 
 
Protocol Number:  
UCLA Bioflo 2016 
 
Principal Investigator: 
Edward W. Lee, MD, PhD 
757 Westwood Plaza #2125               
  
  
Los Angeles, CA 90095  
 
 
 
      
310.267.8771 
EdwardLee@mednet.ucla.edu 
 
 
Last Update : 
 
08/03/2016

BioFlo Study Protocol 
 
1. Objectives 
a. Specific Aims: 
i. To investigate the clinical efficacy and complications of Bioflo Duramax 
dialysis catheter by comparing and monitoring a catheter thrombosis rate 
and catheter exchange rate of Bioflo Duramax catheter vs. Palindrome 
catheter 
 
b. Objectives 
i. To monitor catheter thrombosis rate and catheter exchange rate of Bioflo 
catheters vs. Palindrome catheters in 1 month. 
ii. To compare a mid-term (3 months) catheter thrombosis rate and catheter 
exchange rate of Bioflo catheters vs. Palindrome catheters 
iii. If necessary, to compare a long-term (6 months) catheter thrombosis rate 
and catheter exchange rate of Bioflo catheters vs. Palindrome catheters 
iv. To perform a cost-analysis and economic burden of using Bioflo catheters 
compared to Palindrome catheters due to catheter thrombosis and 
exchange. 
* Catheter thrombosis is defined as the therapeutic use of tPA to restore 
catheter patency. 
 
2. Study Procedures 
a. Study Design 
i. This is a single-centered, prospective, randomized controlled trial. 
ii. Total N = 60 
iii. Patients will be randomized based on randomized software to either the 
BioFlo Group or Palindrome Group. 
iv. The following information will be obtained at the time of catheter insertion: 
1. Demographic information 
2. Clinical information (e.g. medical history) 
3. Procedure information (e.g. insertion site and length) 
v. The catheter placement procedure will be performed as a standard of care 
and routine procedure performed in the interventional radiology (angio) 
suite and the following is a brief description of the procedure: 
1. The right neck will be prepped and draped in the usual sterile 
fashion. 1% lidocaine will be administered for local anesthesia. The 
right internal jugular vein access will be achieved under ultrasound 
guidance with a micropuncture kit. An .035 Amplatz wire will be 
then advanced into the right atrium. Next, attention will be turned 
to the right upper chest, where an appropriate site will be selected 
for the tunnel and lidocaine will be also administered 
subcutaneously from the upper chest to the neck.  The catheter will 

be then tunneled subcutaneously in a retrograde fashion from a 
skin incision in the chest through the tract. The right neck tract will 
be serially dilated and a peel-away sheath will be placed. The 
catheter will be then advanced to the right atrium as the peel away 
sheath will be removed. The incision in the neck and tunnel site will 
be closed with dermabond. The catheter will be secured to the skin 
with 2-0 silk.  Sterile dressings will be applied.  
 
vi. Each patient will be followed for 3 months (primary endpoint) and/or 6 
months if needed, for the following parameters: 
1. Updated clinical information (e.g. interval medical history) 
2. Hemodialysis information (e.g. flow rate) 
3. Frequency of tPA thrombolysis 
4. Frequency of catheter exchange 
5. Complications 
a. If 3 months follow up data is not statistically significant, 
additional 3 months follow up will be performed. 
 
b. Subject Population 
i. Number of subjects = 60 (30 BioFlo vs. 30 Palindrome) 
ii. 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 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 hypercoagulapathy 
iii. Exclusion Criteria 
1. Short term catheter usage plan (< 1 months) 
2. No right jugular venous access 
3. Catheter use for bone marrow transplant or plasmaphresis 
 
3. Scientific Background and Rationale 
a. Vascular access has always been a significant issue for patients receiving long-term 
hemodialysis. National clinical practice guidelines state that arteriovenous fistulae 
(AVF) are the preferred method of vascular access for chronic hemodialysis.1 
However, in the United States in 2012, 19% of hemodialysis patients still received 
treatment using an indwelling catheter and 77% of dialysis patients in their first 30 

days of end-stage renal disease received treatment using a catheter.2 Catheters are 
advantageous because they are low cost, universally applicable, have easy 
insertion, can insert into multiple sites, and do not require maturation time or 
venipuncture.3 Thus, catheters are still widely used for chronic dialysis treatment 
and there is a pressing need to explore methods to improve catheter use. 
b. Numerous catheter designs have been studied to increase efficacy and minimize 
complications of catheter hemodialysis. Major complications of catheters include 
catheter thrombosis, central venous stenosis, infection, and dialysis inadequacy. 
Catheter 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.  
c. The Palindrome catheter, developed in 2005, has a symmetrical “Z” shape outlet to 
reduce the risk of poor blood flow and increase dialysis adequacy.4 It is widely used 
for hemodialysis purposes in United States hospitals today. According to the 
AngioDynamics Inc. manual, BioFlo DuraMax is the first dialysis catheter created 
with Endexo technology and is made of more catheter thrombosis-resistant 
material.5 Benchtop testing using bovine blood showed that the BioFlo DuraMax 
catheter has 84% less thrombus accumulation compared to non-coated Palindrome 
dialysis catheters.5 Although this result is not indicative of clinical outcomes, it is 
still a promising development for hemodialysis treatment.  In clinical setting, this 
finding translates as less in-catheter thrombosis and therefore, less thrombolytic 
tPA usage for decloting the catheter and less frequent catheter exchange.  
d. In this study, we will perform a single center, prospective, randomized controlled 
short-term study comparing the mainstream Palindrome catheter to the new 
BioFlo DuraMax catheter with a focus on catheter thrombosis rate and catheter 
exchange rate. Currently in the literature, no studies exist which compare BioFlo 
catheters to other hemodialysis catheters on the market. This study is unique 
because it is the first investigation to provide clinical data examining the clinical 
advantages of the BioFlo DuraMax dialysis catheter compared to another major 
hemodialysis catheter. 
 
4. Monitoring and Safety Mechanisms 
a. The data security will be followed by OHRPP Data Security in Research guidance 
and procedures.  Clinical data will be entered into a database; each patient will be 
assigned a unique identifier. The key to the code that links to individual patients 
will be maintained on a separate secure computer behind the UCLA firewall with 
encryption; controlled access privileges based on user ID and password will be 
used on the hardware storing the key as well as the clinical database under the 
authority of the investigators.  All electronic data will be fully encrypted and 
password-protected and they will only be stored in the secure network server 
provided by our IT department.  Any hardcopy data will be locked in a locked file 
cabinet or locked room with a limited access by only authorized personnel.  At the 
completion of the study, all data files will be completely stripped of personal 
identifiers and key to the code will be destroyed. 
b. Patient safety monitoring will be performed routinely by the patient’s primary care 
physician, nephrologist, interventional radiologist and the dialysis center staff as 
these end staged renal disease patients are very closely monitored by several 
multi-disciplinary team.  Any adverse events or unforeseen complications may 
arise after the procedure and during the follow up period.  These will be promptly 

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i. The main data collection for measurement of efficacy/complication is to 
monitor the number of tPA being infused at each dialysis session per each 
catheter. 
c. This project has a single primary endpoint at 3 months with comparing a catheter 
thrombosis rate at 3 months.  Our description of having 1 month and 6 months 
follow up may have caused some confusion of having multiple primary endpoints.  
The 1 month follow up is for purely to confirm that the patient is not lost to follow 
up.