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

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
Sponsor:
Collaborator:
Angiodynamics, Inc.
Information provided by (Responsible Party):
Dr. Sandra Donnelly, William Osler Health System

Tracking Information
First Submitted Date  ICMJE March 20, 2017
First Posted Date  ICMJE April 12, 2017
Last Update Posted Date November 5, 2019
Actual Study Start Date  ICMJE August 29, 2016
Actual Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2017)
Resource utilization related to hemodialysis catheter placement - tPA [ Time Frame: 1 year ]
vials of tPA utilized (unit)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2017)
Incidence of catheter-related complications [ Time Frame: 1 year ]
Includes thrombosis, infection, and any other catheter-related complications
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Access in Dialysis for Better Outcomes in Patient Therapy
Official Title  ICMJE A Pragmatic Multicenter Pilot Trial Evaluating the Cost-Effectiveness of BioFlo DuraMax Hemodialysis Catheter vs Standard of Care Catheter
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Central Venous Catheter
  • Catheter-Related Bloodstream Infection (CRBSI) Nos
Intervention  ICMJE
  • Device: BioFlo DuraMax Chronic Hemodialysis Catheter
  • Device: Standard of Care Catheter
Study Arms  ICMJE
  • Standard of Care Device
    Current standard of care polyurethane catheter used at the hospital
    Intervention: Device: Standard of Care Catheter
  • Study Device
    BioFlo DuraMax Chronic Hemodialysis Catheter
    Intervention: Device: BioFlo DuraMax Chronic Hemodialysis Catheter
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 31, 2019)
92
Original Estimated Enrollment  ICMJE
 (submitted: April 6, 2017)
128
Actual Study Completion Date  ICMJE June 30, 2019
Actual Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03109574
Other Study ID Numbers  ICMJE VA-BF410
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Dr. Sandra Donnelly, William Osler Health System
Original Responsible Party Angiodynamics, Inc.
Current Study Sponsor  ICMJE William Osler Health System
Original Study Sponsor  ICMJE Angiodynamics, Inc.
Collaborators  ICMJE Angiodynamics, Inc.
Investigators  ICMJE
Principal Investigator: Sandra Donnelly, MD William Osler Health System
PRS Account William Osler Health System
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP