End Stage Renal DiseaseNCT00157664
Long Study - Longitudinal Thrombosis in End Stage Renal Disease
An observational study of End Stage Renal Disease and Thrombosis, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
The primary focus of this study is to collect information through diagnostic testing, blood sample analysis and patient data collection on patients starting hemodialysis to determine risk and preventative factors of bleeding and clotting events. 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
- How many people
- 400 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2004to Dec 2008
- Phase
- Observational
- 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
Study population: Adult subjects initiating dialysis
Who may be able to join
- Adult patient (aged > 18 years)
- Patient on hemodialysis between 30 and 90 days
Who cannot join
- Anticipated recovery of renal function (on dialysis < 90 days)
- Critical illness at time of recruitment (patients who are critically ill [ICU] when first screened, who survive to 80 days, will be rescreened and will be able to participate at that point if no longer critically ill)
- Planned live-donor renal transplant within 6 months
- Patient cannot consent due to language barrier
- Patient cannot consent due to cognitive difficulties
- Patient cannot consent due to hearing impairment
Show all 10Show fewer
- Patient cannot consent due to speech impairment
- Patient or decision maker declines consent
- Patient is unable to give consent and no substitute decision maker is available
- Patient on dialysis longer than 90 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Canadian Longitudinal Thrombosis in End Stage Renal Disease Pilot Study
The primary focus of this study is to collect information through diagnostic testing, blood sample analysis and patient data collection on patients starting hemodialysis to determine risk and preventative factors of bleeding and clotting events.
Read the detailed description
Hemodialysis patients have a very high rate of heart attacks, strokes and amputation. These problems are caused by a blood vessel problem called atherosclerosis (hardening of the arteries), and by clotting. Clotting is also a problem in the access, which is their lifeline for hemodialysis. We have early results which show that some risk factors for clotting in the general population are common in dialysis patients. Bleeding is another significant problem within this population. In this pilot study we will measure bleeding/clotting factors in the blood of consenting patients who are just starting dialysis. We will also do special tests to show how much calcium build up and atherosclerotic build up has happened in the arteries and whether the arteries are becoming stiff. We will then follow patients for up to four years and record any health problems that might reflect bleeding, clotting or a blood vessel problem. At the end of the study, we will compare people who have had bleeding, clotting or blood vessel problem with those who have not, and learn which of the measurements predicted problems. We will go on to study potential treatments, such as anti-clotting drugs, which might prevent or delay the occurrence of such problems. This would improve the health of dialysis patients.
- Conditions
- End Stage Renal Disease, Thrombosis, Bleeding, Cardiovascular Disease
- Medical subject headings
- Kidney Failure, Chronic, Thrombosis, Hemorrhage, Cardiovascular Diseases
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 startJul 2004
- Primary completionMay 2008 (estimated)
- Study completionDec 2008 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Investigators
- Alistair J Ingram, MD, Principal investigator, Associate Professor, MedicineCatherine M Clase, MD, Principal investigator, Associate Professor, MedicineMark A Crowther, MD, Principal investigator, Associate Professor, Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00157664
- Sponsor's protocol ID
- MOP - 64452
- Status last verified
- Jun 2008
- First submitted
- 7 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
- Canadian Longitudinal Thrombosis in End Stage Renal Disease Pilot Study
- ClinicalTrials.gov ID
- NCT00157664
- Acronym / sponsor ID
- MOP - 64452
- Conditions
- End Stage Renal Disease, Thrombosis, Bleeding, Cardiovascular Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Jul 2004
- Primary completion
- May 2008 (estimated)
- Study completion
- Dec 2008 (estimated)
- 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.
The primary focus of this study is to collect information through diagnostic testing, blood sample analysis and patient data collection on patients starting hemodialysis to determine risk and preventative factors of bleeding and clotting events.
Detailed description
Hemodialysis patients have a very high rate of heart attacks, strokes and amputation. These problems are caused by a blood vessel problem called atherosclerosis (hardening of the arteries), and by clotting. Clotting is also a problem in the access, which is their lifeline for hemodialysis. We have early results which show that some risk factors for clotting in the general population are common in dialysis patients. Bleeding is another significant problem within this population. In this pilot study we will measure bleeding/clotting factors in the blood of consenting patients who are just starting dialysis. We will also do special tests to show how much calcium build up and atherosclerotic build up has happened in the arteries and whether the arteries are becoming stiff. We will then follow patients for up to four years and record any health problems that might reflect bleeding, clotting or a blood vessel problem. At the end of the study, we will compare people who have had bleeding, clotting or blood vessel problem with those who have not, and learn which of the measurements predicted problems. We will go on to study potential treatments, such as anti-clotting drugs, which might prevent or delay the occurrence of such problems. This would improve the health of dialysis patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects initiating dialysis
Key inclusion criteria (2 listed)
- Adult patient (aged > 18 years)
- Patient on hemodialysis between 30 and 90 days
Key exclusion criteria (10 listed)
- Anticipated recovery of renal function (on dialysis < 90 days)
- Critical illness at time of recruitment (patients who are critically ill [ICU] when first screened, who survive to 80 days, will be rescreened and will be able to participate at that point if no longer critically ill)
- Planned live-donor renal transplant within 6 months
- Patient cannot consent due to language barrier
- Patient cannot consent due to cognitive difficulties
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
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
Mark A Crowther, 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?
An observational study of 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 2 inclusion and 10 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: status not confirmed, 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. 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?
Results are not available in the source record.
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.
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.