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Investigation of Platelet Function and Aspirin Resistance in Chronic Dialysis Patient

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2009 by National Taiwan University Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01045785
First Posted: January 11, 2010
Last Update Posted: January 11, 2010
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.
Information provided by:
National Taiwan University Hospital
  Purpose
The purpose of this study is to determine whether aspirin resistance has impact on cardiovascular event in dialysis patient.

Condition
End Stage Renal Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Investigation of Platelet Function and Aspirin Resistance in Chronic Dialysis Patient

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

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

Estimated Enrollment: 300
Study Start Date: December 2009
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
aspirin responsive
PFA Col/EPI normal
aspirin resistance
PFA Col/epi showed resistance

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
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
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01045785


Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Jenqwen Huang, MD National Taiwan University Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Jenqwen Huang, Internal Medicine, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01045785     History of Changes
Other Study ID Numbers: 200912018R
First Submitted: January 8, 2010
First Posted: January 11, 2010
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:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics