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

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ClinicalTrials.gov Identifier: NCT03109574
Recruitment Status : Unknown
Verified March 2017 by Angiodynamics, Inc..
Recruitment status was:  Enrolling by invitation
First Posted : April 12, 2017
Last Update Posted : April 12, 2017
Sponsor:
Collaborator:
William Osler Health System
Information provided by (Responsible Party):
Angiodynamics, Inc.

Study Description
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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 tPA usage, catheter exchange rates, catheter patency, and missed dialysis days.

Condition or disease Intervention/treatment Phase
Central Venous Catheter Catheter-Related Bloodstream Infection (CRBSI) Nos Device: BioFlo DuraMax Chronic Hemodialysis Catheter Device: Standard of Care Catheter Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 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
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arms and Interventions
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Arm Intervention/treatment
Standard of Care Device
Current standard of care polyurethane catheter used at the hospital
 Device: Standard of Care Catheter
Study Device
BioFlo DuraMax Chronic Hemodialysis Catheter
 Device: BioFlo DuraMax Chronic Hemodialysis Catheter


Outcome Measures
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Primary Outcome Measures :
  1. Resource utilization related to hemodialysis catheter placement - tPA [ Time Frame: 1 year ]
    vials of tPA utilized (unit)


Secondary Outcome Measures :
  1. Incidence of catheter-related complications [ Time Frame: 1 year ]
    Includes thrombosis, infection, and any other catheter-related complications


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Canada, Ontario
William Osler Health System
Brampton, Ontario, Canada
Niagara Health System
Saint Catharines, Ontario, Canada, L2S 0A9
Sponsors and Collaborators
Angiodynamics, Inc.
William Osler Health System
Investigators
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Principal Investigator: Sandra Donnelly, MD William Osler Health System
More Information
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Responsible Party: Angiodynamics, Inc.
ClinicalTrials.gov Identifier: NCT03109574     History of Changes
Other Study ID Numbers: VA-BF410
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: March 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes