Clinical trial NCT00157664: Long Study - Longitudinal Thrombosis in End Stage Renal Disease
Official title: Canadian Longitudinal Thrombosis in End Stage Renal Disease Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: End Stage Renal Disease
Thrombosis
Bleeding
Cardiovascular Disease
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2005-09-12
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult subjects initiating dialysis

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.

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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Hospital
state: Ontario
Study officials:
affiliation: Associate Professor, Medicine
name: Alistair J Ingram, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor, Medicine
name: Catherine M Clase, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor, Medicine
name: Mark A Crowther, MD
role: PRINCIPAL_INVESTIGATOR
References: