NCT02796300

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 10, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

January 20, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2019

Completed
10 months until next milestone

Results Posted

Study results publicly available

April 13, 2020

Completed
Last Updated

August 13, 2020

Status Verified

July 1, 2020

Enrollment Period

2.2 years

First QC Date

May 24, 2016

Results QC Date

March 26, 2020

Last Update Submit

July 30, 2020

Conditions

Chronic Kidney Disease

Keywords

biofloDuramax catheterdialysis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters.

    3 months

  • Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters.

    6 months

  • Cost Analysis

    3 months

Study Arms (2)

Bioflo Goup

ACTIVE COMPARATOR

This group will have dialysis using the Bioflo catheter.

Device: Bioflo Dialysis Catheter

Palindrome Group

ACTIVE COMPARATOR

This group will have dialysis using the Palindrome catheter.

Device: Palindrome Dialysis Catheter

Interventions

Bioflo Dialysis CatheterDEVICE

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.

Bioflo Goup
Palindrome Dialysis CatheterDEVICE

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

An early termination occurred due to the decision made by the sponsor and PI. This led to smaller numbers of subjects analyzed than originally planned.

Results Point of Contact

Title
Principal Investigator
Organization
UCLA Medical Center
EdwardLee@mednet.ucla.edu
310-267-8771

Study Officials

  • Edward Lee, MD, PhD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

May 24, 2016

First Posted

June 10, 2016

Study Start

January 20, 2017

Primary Completion

March 27, 2019

Study Completion

June 25, 2019

Last Updated

August 13, 2020

Results First Posted

April 13, 2020

Record last verified: 2020-07

Locations

US(1)