Aspirin and the Risk of Microscopic Hematuria in Asymptomatic Screened Population

August 27, 2012 updated by: Sang Eun Lee, Seoul National University Hospital
Aspirin can increase the risk of bleeding tendency. However, correlation between aspirin treatment and hematuria in general population is not well known. The investigators will evaluate whether daily use of aspirin increase the risk of microscopic hematuria in healthy large screened populations.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

60048

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

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
        • Seoul National University Bundang 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 to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Asymptomatic general population who underwent general health screening program

Description

Inclusion Criteria:

  • Age ≥ 20 years, male or female

Exclusion Criteria:

  • No result of urinalysis
  • No record of medical history (including medication)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence rate of the microscopic hematuria
Time Frame: at the screening
>4 RBC/HPF in urine microscopy
at the screening

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection rate of significant cause for microscopic hematuria
Time Frame: whitin 12 months after screening
  • Among participants who had microscopic hematuria at the screening
  • By imaging study or cystoscopy
  • At the screening or within 12 months after screening

  • Significant cause for microscopic hematuria

    1. urinary stone
    2. renal mass (benign or malignant / not simple cyst)
    3. urothelial cancer
    4. other lesions (clinically relevant lesions determined by researchers)
whitin 12 months after screening
Incidence rate of persistent microscopic hematuria
Time Frame: within 12 months
  • Among participants who had microscopic hematuria at the screening
  • Determined by repeated urine microscopy
within 12 months

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Collaborators

Seoul National University Bundang Hospital

Investigators

  • Principal Investigator: Sang Eun Lee, selee@snubh.org, Seoul National University Bundang Hospital

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

August 1, 2012

Primary Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

June 6, 2012

First Submitted That Met QC Criteria

June 7, 2012

First Posted (Estimate)

June 8, 2012

Study Record Updates

Last Update Posted (Estimate)

August 28, 2012

Last Update Submitted That Met QC Criteria

August 27, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUBH-URO-2012-01

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.

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