End Stage Renal DiseasePhase 3NCT00157651
Access II - Trial of Warfarin to Prevent Malfunction of Haemodialysis Catheters
A Phase 3 study testing warfarin in people with End Stage Renal Disease and Thrombosis, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
This study examines whether low intensity, dose adjusted warfarin prolongs the time to mechanical failure of hemodialysis catheters without resulting in an unacceptable rate of bleeding. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Thrombosis, Bleeding
- What is being tested?
- warfarin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 1 siteCanada
- Study dates
- Feb 1999to Mar 2007
- Phase
- Phase 3
- 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
- Newly placed double-lumen hemodialysis catheter
Who cannot join
- Major bleed within last 3 months
- Platelet count less than 50 x 10 9/L or current coagulopathy (most recent INR > 1.5, not due to warfarin)
- Active peptic ulcer disease
- Anticipated need for invasive intervention within next 2 weeks
- Taking warfarin for an indication other than access prophylaxis
- Allergic to, or intolerant of, warfarin
Show all 13Show fewer
- Pregnant
- Woman of child-bearing age who has not agreed to use an adequate method of birth control for the duration of the study
- Catheter likely needed for 2 weeks or less
- Patient previously took part in the study
- Patient has known aortic aneurysm of 6cm or greater
- Patients nephrologist has refused consent
- Patient has refused consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Placebo Controlled, Randomized Trial of Low-Intensity Adjusted-Dose Warfarin for the Prevention of Mechanical Malfunction of Double-Lumen Haemodialysis Catheters
This study examines whether low intensity, dose adjusted warfarin prolongs the time to mechanical failure of hemodialysis catheters without resulting in an unacceptable rate of bleeding.
Read the detailed description
Patients with end-stage renal disease receiving or about to initiate hemodialysis are randomized to receive either adjusted dose warfarin to achieve an INR of 1.5-1.9 or adjusted dose placebo within 72 hours of hemodialysis catheter placement. The primary outcome is mechanical failure of the catheter, as outlined below.
- Conditions
- End Stage Renal Disease, Thrombosis, Bleeding
- Being tested
- warfarin, placebo
- Keywords
- end stage renal disease, thrombosis, bleeding
- Medical subject headings
- Kidney Failure, Chronic, Thrombosis, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
warfarinDrug
Also called Coumadin
Daily oral warfarin with INR monitored weekly, adjusted to keep INR between 1.5 and 1.9
placeboDrug
Also called no other names
matching placebo for warfarin, adjusted according to sham INR generated by unblinded warfarin monitor
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Receiving warfarin Receives: Drug: warfarin |
| 2 | Placebo comparator | Receiving matching placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from catheter insertion to mechanical failure. This is defined as inability to aspirate or persistent blood flow less than 200mL/min after line reversal, patient repositioning and rotational manipulation of the catheter.
Measured: monthly
Secondary outcomes (3)
Blood flow rate and adequacy of dialysis.
Measured: monthly
Major bleeding events.
Measured: monthly
Death from any cause.
Measured: monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startFeb 1999
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Investigators
- Alistair J Ingram, MD, Principal investigator, Associate Professor, MedicineCatherine M Clase, MD, Principal investigator, Associate Professor, Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00157651
- Sponsor's protocol ID
- MCT-15226
- Status last verified
- Jun 2008
- First submitted
- 8 Sep 2005
- Last updated
- 17 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo Controlled, Randomized Trial of Low-Intensity Adjusted-Dose Warfarin for the Prevention of Mechanical Malfunction of Double-Lumen Haemodialysis Catheters
- ClinicalTrials.gov ID
- NCT00157651
- Acronym / sponsor ID
- MCT-15226
- Conditions
- End Stage Renal Disease, Thrombosis, Bleeding
- Keywords
- end stage renal disease, thrombosis, bleeding
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- Feb 1999
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 12 Sep 2005 (estimated)
- 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 study examines whether low intensity, dose adjusted warfarin prolongs the time to mechanical failure of hemodialysis catheters without resulting in an unacceptable rate of bleeding.
Detailed description
Patients with end-stage renal disease receiving or about to initiate hemodialysis are randomized to receive either adjusted dose warfarin to achieve an INR of 1.5-1.9 or adjusted dose placebo within 72 hours of hemodialysis catheter placement. The primary outcome is mechanical failure of the catheter, as outlined below.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: warfarinReceiving warfarin |
| 2 | Placebo comparator | Drug: placeboReceiving matching placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Newly placed double-lumen hemodialysis catheter
Key exclusion criteria (13 listed)
- Major bleed within last 3 months
- Platelet count less than 50 x 10 9/L or current coagulopathy (most recent INR > 1.5, not due to warfarin)
- Active peptic ulcer disease
- Anticipated need for invasive intervention within next 2 weeks
- Taking warfarin for an indication other than access prophylaxis
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 |
|---|---|---|
| warfarinAlso: CoumadinDaily oral warfarin with INR monitored weekly, adjusted to keep INR between 1.5 and 1.9 | Drug | 1 |
| placeboAlso: no other namesmatching placebo for warfarin, adjusted according to sham INR generated by unblinded warfarin monitor | Drug | 2 |
Primary outcome
Time from catheter insertion to mechanical failure. This is defined as inability to aspirate or persistent blood flow less than 200mL/min after line reversal, patient repositioning and rotational manipulation of the catheter.
Time frame: monthly
3 secondary outcomes
Blood flow rate and adequacy of dialysis.
Time frame: monthly
Major bleeding events.
Time frame: monthly
Death from any cause.
Time frame: monthly
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 17 Jun 2008.
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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.
Alistair J Ingram, MD principal investigator
Associate Professor, Medicine
Catherine M Clase, MD principal investigator
Associate Professor, Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing warfarin in people with End Stage Renal Disease and Thrombosis, run by Hamilton Health Sciences Corporation at 1 site 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 1 inclusion and 13 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 17 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time from catheter insertion to mechanical failure. This is defined as inability to aspirate or persistent blood flow less than 200mL/min after line reversal, patient repositioning and rotational manipulation of the catheter. (time frame: monthly). 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 17 Jun 2008.