Trial Outcomes & Findings for Study to Compare Palindrome vs. BioFlo DuraMax Dialysis Catheters (NCT NCT02796300)

Results Overview

A comparison of the number of tPA used as an indicator of thrombosed catheter per month between two groups

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

32 participants

Primary outcome timeframe

1 month

Results posted on

2020-08-13

Participant Flow

Recruitment period = 01/2017 to 12/2018 Location = UCLA Santa Monica Hospital

No significant events occurred in this study prior to assignment to a group

Participant milestones

Participant milestones
Measure	Bioflo Goup This group will have dialysis using the Bioflo catheter. Bioflo Dialysis Catheter: 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.	Palindrome Group This group will have dialysis using the Palindrome catheter. Palindrome Dialysis Catheter: 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.
Overall Study STARTED	10	22
Overall Study COMPLETED	10	22
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bioflo Goup n=10 Participants This group will have dialysis using the Bioflo catheter. Bioflo Dialysis Catheter: 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.	Palindrome Group n=22 Participants This group will have dialysis using the Palindrome catheter. Palindrome Dialysis Catheter: 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.	Total n=32 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=10 Participants	0 Participants n=22 Participants	0 Participants n=32 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=10 Participants	10 Participants n=22 Participants	18 Participants n=32 Participants
Age, Categorical >=65 years	2 Participants n=10 Participants	12 Participants n=22 Participants	14 Participants n=32 Participants
Age, Continuous	50.2 years STANDARD_DEVIATION 14.7 • n=10 Participants	61.2 years STANDARD_DEVIATION 18.6 • n=22 Participants	57.8 years STANDARD_DEVIATION 18.0 • n=32 Participants
Sex: Female, Male Female	3 Participants n=10 Participants	7 Participants n=22 Participants	10 Participants n=32 Participants
Sex: Female, Male Male	7 Participants n=10 Participants	15 Participants n=22 Participants	22 Participants n=32 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	10 participants n=10 Participants	22 participants n=22 Participants	32 participants n=32 Participants

PRIMARY outcome

Timeframe: 1 month

A comparison of the number of tPA used as an indicator of thrombosed catheter per month between two groups

Outcome measures

Outcome measures
Measure	Bioflo Goup n=10 Participants This group will have dialysis using the Bioflo catheter. Bioflo Dialysis Catheter: 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.	Palindrome Group n=22 Participants This group will have dialysis using the Palindrome catheter. Palindrome Dialysis Catheter: 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.
Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters.	4.3 catheter thrombosis per month Standard Error 0.56	7.27 catheter thrombosis per month Standard Error 0.49

SECONDARY outcome

Timeframe: 3 months

Population: Two patients in the Palindrome group were not included in this outcome measure analysis. One patient received the kidney transplant during the 3 month follow-up and the second patient died during the 3 month follow-up

A comparison of the number of tPA used as an indicator of thrombosed catheter per month between two groups in three month follow-up

Outcome measures

Outcome measures
Measure	Bioflo Goup n=10 Participants This group will have dialysis using the Bioflo catheter. Bioflo Dialysis Catheter: 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.	Palindrome Group n=20 Participants This group will have dialysis using the Palindrome catheter. Palindrome Dialysis Catheter: 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.
Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters.	8.6 catheter thrombosis per 3 months Standard Error 0.81	12.4 catheter thrombosis per 3 months Standard Error 1.07

SECONDARY outcome

Timeframe: 6 months

Population: 6 month data were not collected due to a stopping rule invoked after the 3-month data were analyzed

If necessary, we will monitor the catheter thrombosis rate of Bioflo catheters vs. Palindrome catheters.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: Two patients in the Palindrome group were not included in this outcome measure analysis. One patient received the kidney transplant during the 3 month follow-up and the second patient died during the 3 month follow-up

To perform a cost-analysis and economic burden of using Bioflo catheters compared to Palindrome catheters due to catheter thrombosis and exchange.

Outcome measures

Outcome measures
Measure	Bioflo Goup n=10 Participants This group will have dialysis using the Bioflo catheter. Bioflo Dialysis Catheter: 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.	Palindrome Group n=20 Participants This group will have dialysis using the Palindrome catheter. Palindrome Dialysis Catheter: 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.
Cost Analysis	60200 US Dollar Standard Error 5638.75	78909 US Dollar Standard Error 8716.53

Adverse Events

Bioflo Goup

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Palindrome Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Principal Investigator

UCLA Medical Center

Phone: 310-267-8771

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place