This trial is active, not recruiting.

Conditions end stage renal disease, thrombosis, bleeding, cardiovascular disease
Sponsor Hamilton Health Sciences Corporation
Collaborator Canadian Institutes of Health Research (CIHR)
Start date July 2004
End date May 2008
Trial size 400 participants
Trial identifier NCT00157664, MOP - 64452


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Canadian Longitudinal Thrombosis in End Stage Renal Disease Pilot Study
Principal investigator Alistair J Ingram, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2008.
Information provided to ClinicalTrials.gov by McMaster University.