Long Study - Longitudinal Thrombosis in End Stage Renal Disease

Canadian Longitudinal Thrombosis in End Stage Renal Disease Pilot Study

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.

Study Overview

• Status: Unknown
• Conditions: Cardiovascular Disease; Thrombosis; Bleeding; End Stage Renal 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
• Enrollment (Anticipated): 400

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • St. Joseph's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult subjects initiating dialysis

Description

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

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Hamilton Health Sciences Corporation
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: July 1, 2004
• Primary Completion (Anticipated): May 1, 2008
• Study Completion (Anticipated): December 1, 2008

Study Registration Dates

• First Submitted: September 7, 2005
• First Submitted That Met QC Criteria: September 10, 2005
• First Posted (Estimate): September 12, 2005

Study Record Updates

• Last Update Posted (Estimate): June 17, 2008
• Last Update Submitted That Met QC Criteria: June 16, 2008
• Last Verified: June 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Urologic Diseases; Renal Insufficiency; Embolism and Thrombosis; Renal Insufficiency, Chronic; Cardiovascular Diseases; Kidney Diseases; Kidney Failure, Chronic; Thrombosis
• Other Study ID Numbers: MOP - 64452