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Investigation of Platelet Function and Aspirin Resistance in Chronic Dialysis Patient

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01045785
Collaborator
(none)
300
Enrollment
1
Location
7
Duration (Months)
43.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated 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 :
    Dec 1, 2009
    Anticipated Primary Completion Date :
    Jun 1, 2010
    Anticipated Study Completion Date :
    Jul 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    aspirin responsive

    PFA Col/EPI normal
    aspirin resistance

    PFA Col/epi showed resistance

    Outcome Measures

    Primary Outcome Measures

    1. cardiovascular event, bleeding event,and thrombosis [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Taiwan University Hospital Taipei Taiwan 100

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    • Principal Investigator: Jenqwen Huang, MD, National Taiwan University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01045785
    Other Study ID Numbers:
    • 200912018R
    First Posted:
    Jan 11, 2010
    Last Update Posted:
    Jan 11, 2010
    Last Verified:
    Dec 1, 2009
    Keywords provided by , ,
    aspirin resistance, platelet function assay, dialysis, end stage renal disease
    Additional relevant MeSH terms:
    Kidney Diseases
    Kidney Failure, Chronic

    Study Results

    No Results Posted as of Jan 11, 2010