Investigation of Platelet Function and Aspirin Resistance in Chronic Dialysis Patient
Recruitment status was Active, not recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | January 8, 2010 | ||||
| Last Updated Date | January 8, 2010 | ||||
| Start Date ICMJE | December 2009 | ||||
| Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
cardiovascular event, bleeding event,and thrombosis [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Investigation of Platelet Function and Aspirin Resistance in Chronic Dialysis Patient | ||||
| Official Title ICMJE | 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. |
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| 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 ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Cross-Sectional |
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| 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 |
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| Condition ICMJE | End Stage Renal Disease | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 300 | ||||
| Estimated Completion Date | July 2010 | ||||
| Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 20 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Taiwan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01045785 | ||||
| Other Study ID Numbers ICMJE | 200912018R | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Jenqwen Huang, Internal Medicine, National Taiwan University Hospital | ||||
| Study Sponsor ICMJE | National Taiwan University Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | National Taiwan University Hospital | ||||
| Verification Date | December 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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