Investigation of Platelet Function and Aspirin Resistance in Chronic Dialysis Patient

January 8, 2010 updated by: National Taiwan University Hospital
The purpose of this study is to determine whether aspirin resistance has impact on cardiovascular event in dialysis patient.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Dialysis patients which follow-up at least monthly at National Taiwan University Hospital

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
aspirin responsive
PFA Col/EPI normal
aspirin resistance
PFA Col/epi showed resistance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cardiovascular event, bleeding event,and thrombosis
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Anticipated)

June 1, 2010

Study Completion (Anticipated)

July 1, 2010

Study Registration Dates

First Submitted

January 8, 2010

First Submitted That Met QC Criteria

January 8, 2010

First Posted (Estimate)

January 11, 2010

Study Record Updates

Last Update Posted (Estimate)

January 11, 2010

Last Update Submitted That Met QC Criteria

January 8, 2010

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200912018R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on End Stage Renal Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe