Access in Dialysis for Better Outcomes in Patient Therapy | NCT03109574

Studies
Access in Dialysis for Better Outcomes in Patient Therapy

NCT03109574

Sponsor

William Osler Health System

Status

Completed

Last Update Posted

Nov 5, 2019Actual

Enrollment

92Actual

Phase

Not Applicable

Conditions

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

Interventions

BioFlo DuraMax Chronic Hemodialysis Catheter
Standard of Care Catheter

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 29, 2016Actual

Primary Completion Date

Jun 30, 2019Actual

Completion Date

Jun 30, 2019Actual

First Submitted Date

Mar 20, 2017

First Submission Date that Met QC Criteria

Apr 6, 2017

First Posted Date

Apr 12, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 31, 2019

Last Update Posted Date

Nov 5, 2019Actual

Name	Class
Angiodynamics, Inc.	INDUSTRY

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

92Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard of Care Device	Other	Current standard of care polyurethane catheter used at the hospital	Device: Standard of Care Catheter
Study Device	Other	BioFlo DuraMax Chronic Hemodialysis Catheter	Device: BioFlo DuraMax Chronic Hemodialysis Catheter

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BioFlo DuraMax Chronic Hemodialysis Catheter	Device		Study Device
Standard of Care Catheter

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Resource utilization related to hemodialysis catheter placement - tPA	vials of tPA utilized (unit)	1 year

Secondary Outcomes

Measure	Description	Time Frame
Incidence of catheter-related complications	Includes thrombosis, infection, and any other catheter-related complications	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility 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 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
William Osler Health System		Brampton	Ontario	L6R 3J7	Canada
Halton Healthcare

ID	Term
D011707	Pyloric Stenosis
D017219	Gastric Outlet Obstruction
D013272	Stomach Diseases
D005767	Gastrointestinal Diseases