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Investigation of Platelet Function and Aspirin Resistance in Chronic Dialysis Patient

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. 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
Information provided by:
National Taiwan University Hospital

Brief Summary:
The purpose of this study is to determine whether aspirin resistance has impact on cardiovascular event in dialysis patient.

Condition or disease
End Stage Renal Disease

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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Investigation of Platelet Function and Aspirin Resistance in Chronic Dialysis Patient
Study Start Date : December 2009
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

aspirin responsive
PFA Col/EPI normal
aspirin resistance
PFA Col/epi showed resistance

Primary Outcome Measures :
  1. cardiovascular event, bleeding event,and thrombosis [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Dialysis patients which follow-up at least monthly at National Taiwan University Hospital

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

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 identifier (NCT number): NCT01045785

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National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
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Principal Investigator: Jenqwen Huang, MD National Taiwan University Hospital
Additional Information:
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Responsible Party: Jenqwen Huang, Internal Medicine, National Taiwan University Hospital Identifier: NCT01045785    
Other Study ID Numbers: 200912018R
First Posted: January 11, 2010    Key Record Dates
Last Update Posted: January 11, 2010
Last Verified: December 2009
Keywords provided by National Taiwan University Hospital:
aspirin resistance, platelet function assay, dialysis, end stage renal disease
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency