Access in Dialysis for Better Outcomes in Patient Therapy (ADOPT)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03109574 |
Recruitment Status :
Completed
First Posted : April 12, 2017
Last Update Posted : November 5, 2019
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Condition or disease | Intervention/treatment | Phase |
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Central Venous Catheter Catheter-Related Bloodstream Infection (CRBSI) Nos | Device: BioFlo DuraMax Chronic Hemodialysis Catheter Device: Standard of Care Catheter | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 92 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Health Services Research |
Official Title: | A Pragmatic Multicenter Pilot Trial Evaluating the Cost-Effectiveness of BioFlo DuraMax Hemodialysis Catheter vs Standard of Care Catheter |
Actual Study Start Date : | August 29, 2016 |
Actual Primary Completion Date : | June 30, 2019 |
Actual Study Completion Date : | June 30, 2019 |
Arm | Intervention/treatment |
---|---|
Standard of Care Device
Current standard of care polyurethane catheter used at the hospital
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Device: Standard of Care Catheter |
Study Device
BioFlo DuraMax Chronic Hemodialysis Catheter
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Device: BioFlo DuraMax Chronic Hemodialysis Catheter |
- Resource utilization related to hemodialysis catheter placement - tPA [ Time Frame: 1 year ]vials of tPA utilized (unit)
- Incidence of catheter-related complications [ Time Frame: 1 year ]Includes thrombosis, infection, and any other catheter-related complications

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03109574
Canada, Ontario | |
William Osler Health System | |
Brampton, Ontario, Canada, L6R 3J7 | |
Halton Healthcare | |
Oakville, Ontario, Canada, L6M 0L8 | |
Niagara Health System | |
Saint Catharines, Ontario, Canada, L2S 0A9 |
Principal Investigator: | Sandra Donnelly, MD | William Osler Health System |
Responsible Party: | Dr. Sandra Donnelly, Clinical Nephrologist, William Osler Health System |
ClinicalTrials.gov Identifier: | NCT03109574 |
Other Study ID Numbers: |
VA-BF410 |
First Posted: | April 12, 2017 Key Record Dates |
Last Update Posted: | November 5, 2019 |
Last Verified: | October 2019 |
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 |
Sepsis Infections Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |