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Long Study - Longitudinal Thrombosis in End Stage Renal Disease

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2008 by McMaster University.
Recruitment status was:  Active, not recruiting
Canadian Institutes of Health Research (CIHR)
Information provided by:
McMaster University Identifier:
First received: September 7, 2005
Last updated: June 16, 2008
Last verified: June 2008
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.

End Stage Renal Disease
Cardiovascular Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Canadian Longitudinal Thrombosis in End Stage Renal Disease Pilot Study

Resource links provided by NLM:

Further study details as provided by McMaster University:

Biospecimen Retention:   Samples Without DNA
serum and plasma

Estimated Enrollment: 400
Study Start Date: July 2004
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
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.

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
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: Catherine Clase Associate Professor of Medicine, McMaster University Identifier: NCT00157664     History of Changes
Other Study ID Numbers: MOP - 64452
Study First Received: September 7, 2005
Last Updated: June 16, 2008

Additional relevant MeSH terms:
Cardiovascular Diseases
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Embolism and Thrombosis
Vascular Diseases
Urologic Diseases
Renal Insufficiency processed this record on April 24, 2017