Access in Dialysis for Better Outcomes in Patient Therapy

Central Venous Catheter Clinical Trial

— ADOPT  

Official title:

A Pragmatic Multicenter Pilot Trial Evaluating the Cost-Effectiveness of BioFlo DuraMax Hemodialysis Catheter vs Standard of Care Catheter

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03109574
• Other study ID #: VA-BF410
• Status: Completed
• Phase: N/A
• Start date: August 29, 2016
• Est. completion date: June 30, 2019

Study information

• Verified date: October 2019
• Source: William Osler Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, multi-center health economic study in Canada. Participants will be randomly assigned to receive either the study or control dialysis catheter. The primary objective is to evaluate resource utilization in Ontario related to hemodialysis catheter placement including tissue plasminogen activator (tPA) usage, catheter exchange rates, catheter patency, and missed dialysis days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Is indicated for a dialysis catheter for the purpose of attaining long-term vascular access for hemodialysis. Long-term vascular access is defined by physician anticipated duration of hemodialysis for three months or longer.

• Is = 18 years of age.

• Is indicated to receive dialysis treatment at a location where dialysis treatment data will be accessible by the study team.

• Is able to comprehend and have signed the Informed Consent Form (ICF) to participate in the study.

Exclusion Criteria:

• Has known or suspected presence of other device-related infection, bacteremia, or septicemia or has been treated with antibiotics for documented or suspected infection within prior 45 days.

• Is receiving prophylactic anti-coagulation or anti-platelet pharmacotherapy for the purpose of central venous catheter (CVC) patency (anti-coagulation or anti-platelet pharmacotherapy for therapeutic indications do not exclude the patient from the study).

• Has severe chronic obstructive lung disease.

• Had past radiation therapy at the prospective insertion site.

• Had previous episodes of venous thrombosis or vascular surgical procedures at the prospective insertion site.

• Has local tissue factors that will prevent proper device stabilization and/or access.

• Has a stent placed in the vessel where the catheter will be placed

• Is pregnant

• History of drug or alcohol abuse in the past 12 months obtained from patient record and/or interview

• Subjects who weigh = 30 kg.

• Has been previously enrolled in this clinical study, or is participating in another clinical study that is contraindicative to the treatment or outcomes of this investigation.

Related Conditions & MeSH terms

• Catheter-Related Bloodstream Infection (CRBSI) Nos
• Central Venous Catheter

Intervention

Device:
• BioFlo DuraMax Chronic Hemodialysis Catheter

• Standard of Care Catheter

Locations

Country	Name	City	State
Canada	William Osler Health System	Brampton	Ontario
Canada	Halton Healthcare	Oakville	Ontario
Canada	Niagara Health System	Saint Catharines	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
William Osler Health System	Angiodynamics, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resource utilization related to hemodialysis catheter placement - tPA	vials of tPA utilized (unit)	1 year
Secondary	Incidence of catheter-related complications	Includes thrombosis, infection, and any other catheter-related complications	1 year