NCT03109574

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 29, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2017

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 12, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

November 5, 2019

Status Verified

October 1, 2019

Enrollment Period

2.8 years

First QC Date

March 20, 2017

Last Update Submit

October 31, 2019

Conditions

Central Venous CatheterCatheter-Related Bloodstream Infection (CRBSI) Nos

Outcome Measures

Primary Outcomes (1)

  • Resource utilization related to hemodialysis catheter placement - tPA

    vials of tPA utilized (unit)

    1 year

Secondary Outcomes (1)

  • Incidence of catheter-related complications

    1 year

Study Arms (2)

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

BioFlo DuraMax Chronic Hemodialysis CatheterDEVICE
Study Device
Standard of Care CatheterDEVICE
Standard of Care Device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

William Osler Health System

Brampton, Ontario, L6R 3J7, Canada

Location

Halton Healthcare

Oakville, Ontario, L6M 0L8, Canada

Location

Niagara Health System

Saint Catharines, Ontario, L2S 0A9, Canada

Location

MeSH Terms

Conditions

Pyloric Stenosis, Hypertrophic

Condition Hierarchy (Ancestors)

Pyloric StenosisGastric Outlet ObstructionStomach DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Sandra Donnelly, MD

    William Osler Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Nephrologist

Study Record Dates

First Submitted

March 20, 2017

First Posted

April 12, 2017

Study Start

August 29, 2016

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

November 5, 2019

Record last verified: 2019-10

Locations

CA(3)