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

This study is currently recruiting participants.
Verified by Assaf-Harofeh Medical Center, November 2006

Sponsored by: Assaf-Harofeh Medical Center
Information provided by: Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT00407368
  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

U.S. FDA Resources

Study Type:   Observational
Study Design:   Longitudinal, Defined Population, Prospective Study

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  Show Detailed Description

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

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


Study ID Numbers:   75/06
First Received:   December 4, 2006
Last Updated:   December 4, 2006
ClinicalTrials.gov Identifier:   NCT00407368
Health Authority:   Israel: Israeli Health Ministry Pharmaceutical Administration

Study placed in the following topic categories:
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 20, 2008




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