Central Venous CatheterADOPTNCT03109574
Access in Dialysis for Better Outcomes in Patient Therapy
A study testing BioFlo DuraMax Chronic Hemodialysis Catheter in people with Central Venous Catheter and Catheter-Related Bloodstream Infection (CRBSI) Nos, run by William Osler Health System at 3 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Venous Catheter, Catheter-Related Bloodstream Infection (CRBSI) Nos
- What is being tested?
- BioFlo DuraMax Chronic Hemodialysis Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 3 sitesCanada
- Study dates
- 29 Aug 2016to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
William Osler Health System
Brampton, Ontario, L6R 3J7
Halton Healthcare
Oakville, Ontario, L6M 0L8
Niagara Health System
Saint Catharines, Ontario, L2S 0A9
About this study
Official title: A Pragmatic Multicenter Pilot Trial Evaluating the Cost-Effectiveness of BioFlo DuraMax Hemodialysis Catheter vs Standard of Care Catheter
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.
- Being tested
- BioFlo DuraMax Chronic Hemodialysis Catheter, Standard of Care Catheter
- Medical subject headings
- Pyloric Stenosis, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioFlo DuraMax Chronic Hemodialysis CatheterDevice
Standard of Care CatheterDevice
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Device | Other | Current standard of care polyurethane catheter used at the hospital Receives: Device: Standard of Care Catheter |
| Study Device | Other | BioFlo DuraMax Chronic Hemodialysis Catheter Receives: Device: BioFlo DuraMax Chronic Hemodialysis Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resource utilization related to hemodialysis catheter placement - tPA
vials of tPA utilized (unit)
Measured: 1 year
Secondary outcomes (1)
Incidence of catheter-related complications
Includes thrombosis, infection, and any other catheter-related complications
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start29 Aug 2016
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Venous CatheterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- William Osler Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Angiodynamics, Inc.
- Responsible party
- Principal investigator, Dr. Sandra Donnelly, William Osler Health System
- Investigators
- Sandra Donnelly, MD, Principal investigator, William Osler Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03109574
- Sponsor's protocol ID
- VA-BF410
- Acronym
- ADOPT
- Status last verified
- Oct 2019
- First submitted
- 20 Mar 2017
- Last updated
- 5 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Multicenter Pilot Trial Evaluating the Cost-Effectiveness of BioFlo DuraMax Hemodialysis Catheter vs Standard of Care Catheter
- ClinicalTrials.gov ID
- NCT03109574
- Acronym / sponsor ID
- ADOPT / VA-BF410
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- William Osler Health SystemUniversity, hospital or other
- Collaborators
- Angiodynamics, Inc.
- Study start
- 29 Aug 2016 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 12 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Device | Other | Device: Standard of Care CatheterCurrent standard of care polyurethane catheter used at the hospital |
| Study Device | Other | Device: BioFlo DuraMax Chronic Hemodialysis CatheterBioFlo DuraMax Chronic Hemodialysis Catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioFlo DuraMax Chronic Hemodialysis Catheter | Device | Study Device |
| Standard of Care Catheter | Device | Standard of Care Device |
Primary outcome
Resource utilization related to hemodialysis catheter placement - tPA
Time frame: 1 year
vials of tPA utilized (unit)
1 secondary outcome
Incidence of catheter-related complications
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Donnelly, MD principal investigator
William Osler Health System
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioFlo DuraMax Chronic Hemodialysis Catheter in people with Central Venous Catheter and Catheter-Related Bloodstream Infection (CRBSI) Nos, run by William Osler Health System at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resource utilization related to hemodialysis catheter placement - tPA (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2019; AzTrials last refreshed its copy on 6 Nov 2026.