Clinical trial NCT03109574: Access in Dialysis for Better Outcomes in Patient Therapy
Official title: A Pragmatic Multicenter Pilot Trial Evaluating the Cost-Effectiveness of BioFlo DuraMax Hemodialysis Catheter vs Standard of Care Catheter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Central Venous Catheter
Catheter-Related Bloodstream Infection (CRBSI) Nos
Lead sponsor: William Osler Health System
Sponsor class: OTHER
Collaborators: name: Angiodynamics, Inc.
First posted: 2017-04-12
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Resource utilization related to hemodialysis catheter placement - tPA
timeFrame: 1 year
Secondary outcomes:
measure: Incidence of catheter-related complications
timeFrame: 1 year
Other outcomes:
Locations:
city: Brampton
country: Canada
facility: William Osler Health System
state: Ontario
city: Oakville
country: Canada
facility: Halton Healthcare
state: Ontario
city: Saint Catharines
country: Canada
facility: Niagara Health System
state: Ontario
Study officials:
affiliation: William Osler Health System
name: Sandra Donnelly, MD
role: PRINCIPAL_INVESTIGATOR
References: