Investigation of Platelet Function and Aspirin Resistance in Chronic Dialysis Patient

End Stage Renal Disease Clinical Trial

Official title:

Investigation of Platelet Function and Aspirin Resistance in Chronic Dialysis Patient

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01045785
• Other study ID #: 200912018R
• Status: Active, not recruiting
• Phase: N/A
• First received: January 8, 2010
• Last updated: January 8, 2010
• Start date: December 2009
• Est. completion date: July 2010

Study information

• Verified date: December 2009
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: July 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiovascular event, bleeding event,and thrombosis		1 year	No

External Links

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