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Investigation of Platelet Function and Aspirin Resistance in Chronic Dialysis Patient

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by National Taiwan University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01045785
First received: January 8, 2010
Last updated: NA
Last verified: December 2009
History: No changes posted
  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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: January 8, 2010
Last Updated: January 8, 2010
Health Authority: Taiwan: Department of Health

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
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases
Aspirin
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014