Long Study - Longitudinal Thrombosis in End Stage Renal Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by McMaster University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00157664
First received: September 7, 2005
Last updated: June 16, 2008
Last verified: June 2008
  Purpose

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
End Stage Renal Disease
Thrombosis
Bleeding
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult subjects initiating dialysis

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00157664

Locations
Canada, Ontario
St. Joseph's Hospital
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
Hamilton Health Sciences Corporation
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
  More Information

No publications provided

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

Additional relevant MeSH terms:
Cardiovascular Diseases
Thrombosis
Kidney Diseases
Kidney Failure, Chronic
Embolism and Thrombosis
Vascular Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on September 18, 2014