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Trial record 19 of 1300 for:    ASPIRIN AND Platelet Aggregation

Investigation of Platelet Function and Aspirin Resistance in Chronic Dialysis Patient

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ClinicalTrials.gov Identifier: NCT01045785
Recruitment Status : Unknown
Verified December 2009 by National Taiwan University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : January 11, 2010
Last Update Posted : January 11, 2010
Sponsor:
Information provided by:
National Taiwan University Hospital

Tracking Information
First Submitted Date January 8, 2010
First Posted Date January 11, 2010
Last Update Posted Date January 11, 2010
Study Start Date December 2009
Estimated Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 8, 2010)
cardiovascular event, bleeding event,and thrombosis [ Time Frame: 1 year ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Investigation of Platelet Function and Aspirin Resistance in Chronic Dialysis Patient
Official Title Investigation of Platelet Function and Aspirin Resistance in Chronic Dialysis Patient
Brief Summary The purpose of this study is to determine whether aspirin resistance has impact on cardiovascular event in dialysis patient.
Detailed Description Dialysis patient inevitably suffered from uremic bleeding although improvement of dialysis care in the past decades. Physicians used to check bleeding time as a surrogate marker for uremic bleeding. However, bleeding time isn't accurate and as well known, is poorly correlated with clinical bleeding such as surgical bleeding. Platelet function assay (PFA) is a newly developed method to measure platelet aggregation in vitro and is validated in many sorts of platelet disorders. Recently, PFA was also used to evaluate aspirin responsiveness in patients who had taken aspirin. Our study is aim to investigate uremic thrombocytopathy via PFA of dialysis patient in Taiwan. Furthermore, we will study aspirin resistance in dialysis patient.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Dialysis patients which follow-up at least monthly at National Taiwan University Hospital
Condition End Stage Renal Disease
Intervention Not Provided
Study Groups/Cohorts
  • aspirin responsive
    PFA Col/EPI normal
  • aspirin resistance
    PFA Col/epi showed resistance
Publications * Bilgin AU, Karadogan I, Artac M, Kizilors A, Bligin R, Undar L. Hemodialysis shortens long in vitro closure times as measured by the PFA-100. Med Sci Monit. 2007 Mar;13(3):CR141-5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: January 8, 2010)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2010
Estimated Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • dialysis >3 months
  • Hb>10 g/dl & Plt > 10000

Exclusion Criteria:

  • using medication which interfere PFA except aspirin
  • terminal disease such as malignancy
  • active vasculitis
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT01045785
Other Study ID Numbers 200912018R
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Jenqwen Huang, Internal Medicine, National Taiwan University Hospital
Study Sponsor National Taiwan University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Jenqwen Huang, MD National Taiwan University Hospital
PRS Account National Taiwan University Hospital
Verification Date December 2009