NCT01615315

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60,048

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 8, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Last Updated

August 28, 2012

Status Verified

August 1, 2012

Enrollment Period

Same day

First QC Date

June 6, 2012

Last Update Submit

August 27, 2012

Conditions

Asymptomatic General PopulationMicroscopic Hematuria

Keywords

aspirinscreeningmicroscopic hematuria

Outcome Measures

Primary Outcomes (1)

  • Incidence rate of the microscopic hematuria

    \>4 RBC/HPF in urine microscopy

    at the screening

Secondary Outcomes (2)

  • Detection rate of significant cause for microscopic hematuria

    whitin 12 months after screening

  • Incidence rate of persistent microscopic hematuria

    within 12 months

Eligibility Criteria

Age20 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Asymptomatic general population who underwent general health screening program

You may qualify if:

  • Age ≥ 20 years, male or female

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Study Officials

  • Sang Eun Lee, selee@snubh.org

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 6, 2012

First Posted

June 8, 2012

Study Start

August 1, 2012

Primary Completion

August 1, 2012

Last Updated

August 28, 2012

Record last verified: 2012-08

Locations

KR(1)