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Platelets Function and Cardiovascular Events in Patients With End Stage Renal Disease

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2006 by Assaf-Harofeh Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00407368
First Posted: December 5, 2006
Last Update Posted: December 5, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Assaf-Harofeh Medical Center
  Purpose

The purpose of this study is to perform a prospective evaluation regarding the relationship between platelets function and cardiovascular events in patients with ESRD.

The study will include 100-200 patients with ESRD, age 18 years or older, treated in the nephrology division of Assaf Harofeh medical center.

The primary end points of the study are cardiovascular events including acute myocardial infarction (defined as symptoms + acute elevation of TnI), need for coronary artery disease revascularization, or acute cerebrovascular event (TIA or CVA) and mortality. The secondary end points are any hospitalization due to acute coronary syndrome, active bleeding with the need for blood transfusion and dialysis access graft thrombosis (time to thrombosis).

Blood will be taken for complete blood count including platelets count and mean platelets volume, serum electrolytes, albumin, blood lipids, Kt/V, troponin and two 5 ml aliquots from each blood collection will be separated and stored at -70co until analyzed for oxidative stress, homocysteine and highly sensitive CRP will be performed. Five mL of blood will be sent for platelets function assessment.

During the follow up period the correlation between platelets function an cardiovascular events will be assessed.


Condition Intervention
End Stage Renal Disease Cardiovascular Disease Procedure: Blood Sample

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Assaf-Harofeh Medical Center:

Estimated Enrollment: 150
Study Start Date: September 2006
Estimated Study Completion Date: December 2007
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The study will include patients with end stage renal disease, age 18 years or older, treated in the nephrology division of Assaf Harofeh medical center.

Exclusion Criteria:

  • Patients will be excluded if their platelets count will be lower then 50,000 cu/mm, if they have known hematologic malignancies, other solid malignancy with life expectancy of less then 1 year or if they are treated with Warfarin (Comadin).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00407368


Contacts
Contact: Shai Efrati, MD +972-577-346364 efratishai@013.net

Locations
Israel
Nephrology Division, Aassaf-Harofeh Medical Center Recruiting
Zerifin, Israel, 70300
Contact: Shai Efrati, MD    +972-577-346364    efratishai@013.net   
Principal Investigator: Mark Katz, MD         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Study Chair: Shai Efrati, MD Assaf-Harofeh Medical Center
Principal Investigator: Mark Katz, MD Assaf-Harofeh Medical Center
  More Information

ClinicalTrials.gov Identifier: NCT00407368     History of Changes
Other Study ID Numbers: 75/06
First Submitted: December 4, 2006
First Posted: December 5, 2006
Last Update Posted: December 5, 2006
Last Verified: November 2006

Additional relevant MeSH terms:
Cardiovascular Diseases
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency