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History of Changes for Study: NCT03109574
Access in Dialysis for Better Outcomes in Patient Therapy (ADOPT)
Latest version (submitted October 31, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 6, 2017 None (earliest Version on record)
2 October 31, 2019 Recruitment Status, Sponsor/Collaborators, Study Status, Study Identification, Contacts/Locations, Study Design, Eligibility and Study Description
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Study NCT03109574
Submitted Date:  April 6, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: VA-BF410
Brief Title: Access in Dialysis for Better Outcomes in Patient Therapy (ADOPT)
Official Title: A Pragmatic Multicenter Pilot Trial Evaluating the Cost-Effectiveness of BioFlo DuraMax Hemodialysis Catheter vs Standard of Care Catheter
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2017
Overall Status: Enrolling by invitation
Study Start: August 29, 2016
Primary Completion: June 2018 [Anticipated]
Study Completion: December 2018 [Anticipated]
First Submitted: March 20, 2017
First Submitted that
Met QC Criteria:
April 6, 2017
First Posted: April 12, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
April 6, 2017
Last Update Posted: April 12, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Angiodynamics, Inc.
Responsible Party: Sponsor
Collaborators: William Osler Health System
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: Yes
Unapproved/Uncleared Device:
Pediatric Postmarket Surveillance:
Data Monitoring: No
Open or close this module Study Description
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.
Detailed Description:
Open or close this module Conditions
Conditions: Central Venous Catheter
Catheter-Related Bloodstream Infection (CRBSI) Nos
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Health Services Research
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Single (Participant)
Allocation: Randomized
Enrollment: 128 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Study Officials: Sandra Donnelly, MD
Principal Investigator
William Osler Health System
Locations: Canada, Ontario
William Osler Health System
Brampton, Ontario, Canada
Niagara Health System
Saint Catharines, Ontario, Canada, L2S 0A9
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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