Access in Dialysis for Better Outcomes in Patient Therapy (ADOPT)

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

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.

Study Overview

• Status: Completed
• Conditions: Central Venous Catheter; Catheter-Related Bloodstream Infection (CRBSI) Nos
• Intervention / Treatment: Device: Standard of Care Catheter; Device: BioFlo DuraMax Chronic Hemodialysis Catheter

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Brampton, Ontario, Canada, L6R 3J7
      • William Osler Health System
    • Oakville, Ontario, Canada, L6M 0L8
      • Halton Healthcare
    • Saint Catharines, Ontario, Canada, L2S 0A9
      • Niagara Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Standard of Care Device; Current standard of care polyurethane catheter used at the hospital	Device: Standard of Care Catheter
Other: Study Device; BioFlo DuraMax Chronic Hemodialysis Catheter	Device: BioFlo DuraMax Chronic Hemodialysis Catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resource utilization related to hemodialysis catheter placement - tPA	vials of tPA utilized (unit)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of catheter-related complications	Includes thrombosis, infection, and any other catheter-related complications	1 year

Collaborators and Investigators

• Sponsor: William Osler Health System
• Collaborators: Angiodynamics, Inc.
• Investigators: Principal Investigator: Sandra Donnelly, MD, William Osler Health System

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2016
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: March 20, 2017
• First Submitted That Met QC Criteria: April 6, 2017
• First Posted (Actual): April 12, 2017

Study Record Updates

• Last Update Posted (Actual): November 5, 2019
• Last Update Submitted That Met QC Criteria: October 31, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis
• Other Study ID Numbers: VA-BF410

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes