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

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ClinicalTrials.gov Identifier: NCT00407368
Recruitment Status : Unknown
Verified November 2006 by Assaf-Harofeh Medical Center.
Recruitment status was:  Recruiting
First Posted : December 5, 2006
Last Update Posted : December 5, 2006
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center

Brief Summary:

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 or disease Intervention/treatment
End Stage Renal Disease Cardiovascular Disease Procedure: Blood Sample

  Show Detailed Description

Study Type : Observational
Enrollment : 150 participants
Observational Model: Defined Population
Time Perspective: Longitudinal
Time Perspective: Prospective
Study Start Date : September 2006
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Failure
U.S. FDA Resources





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).

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

ClinicalTrials.gov Identifier: NCT00407368     History of Changes
Other Study ID Numbers: 75/06
First Posted: December 5, 2006    Key Record Dates
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