Long Study - Longitudinal Thrombosis in End Stage Renal Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00157664
Recruitment Status : Unknown
Verified June 2008 by McMaster University.
Recruitment status was:  Active, not recruiting
First Posted : September 12, 2005
Last Update Posted : June 17, 2008
Canadian Institutes of Health Research (CIHR)
Information provided by:
McMaster University

Brief 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.

Condition or disease
End Stage Renal Disease Thrombosis Bleeding Cardiovascular Disease

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 Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Canadian Longitudinal Thrombosis in End Stage Renal Disease Pilot Study
Study Start Date : July 2004
Estimated Primary Completion Date : May 2008
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Biospecimen Retention:   Samples Without DNA
serum and plasma

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult subjects initiating dialysis

Inclusion Criteria:

  • Adult patient (aged > 18 years)
  • Patient on hemodialysis between 30 and 90 days

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00157664

Canada, Ontario
St. Joseph's Hospital
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Alistair J Ingram, MD Associate Professor, Medicine
Principal Investigator: Catherine M Clase, MD Associate Professor, Medicine
Principal Investigator: Mark A Crowther, MD Associate Professor, Medicine

Responsible Party: Catherine Clase Associate Professor of Medicine, McMaster University Identifier: NCT00157664     History of Changes
Other Study ID Numbers: MOP - 64452
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: June 17, 2008
Last Verified: June 2008

Additional relevant MeSH terms:
Cardiovascular Diseases
Kidney Diseases
Kidney Failure, Chronic
Embolism and Thrombosis
Vascular Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency