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Sponsors and Collaborators: |
Hamilton Health Sciences Canadian Institutes of Health Research (CIHR) |
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Information provided by: | McMaster University |
ClinicalTrials.gov Identifier: | NCT00157664 |
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 |
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End Stage Renal Disease Thrombosis Bleeding Cardiovascular Disease |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Canadian Longitudinal Thrombosis in End Stage Renal Disease Pilot Study |
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) |
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 |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Adult subjects initiating dialysis
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
St. Joseph's Hospital | |
Hamilton, Ontario, Canada, L8N 4A6 |
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: | McMaster University ( Catherine Clase Associate Professor of Medicine ) |
Study ID Numbers: | MOP - 64452 |
Study First Received: | September 7, 2005 |
Last Updated: | June 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00157664 History of Changes |
Health Authority: | Canada: Health Canada |
Embolism and Thrombosis Renal Insufficiency Urologic Diseases Embolism Renal Insufficiency, Chronic Vascular Diseases |
Kidney Failure, Chronic Kidney Diseases Hemorrhage Thrombosis Kidney Failure |
Embolism and Thrombosis Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic Vascular Diseases |
Kidney Failure, Chronic Cardiovascular Diseases Kidney Diseases Thrombosis Kidney Failure |