Access in Dialysis for Better Outcomes in Patient Therapy

Study Overview
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Brief Summary
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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.

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

Conditions
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Central Venous Catheter, Catheter-Related Bloodstream Infection (CRBSI) Nos

Intervention / Treatment
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* Device: BioFlo DuraMax Chronic Hemodialysis Catheter
* Device: Standard of Care Catheter


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |