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Aspirin and the Risk of Microscopic Hematuria in Asymptomatic Screened Population

This study has been completed.
Sponsor:
Collaborator:
Seoul National University Bundang Hospital
Information provided by (Responsible Party):
Sang Eun Lee, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01615315
First received: June 6, 2012
Last updated: August 27, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition
Asymptomatic General Population
Microscopic Hematuria

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective

Resource links provided by NLM:

Drug Information available for: Aspirin
U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Incidence rate of the microscopic hematuria [ Time Frame: at the screening ] [ Designated as safety issue: No ]
    >4 RBC/HPF in urine microscopy


Secondary Outcome Measures:
  • Detection rate of significant cause for microscopic hematuria [ Time Frame: whitin 12 months after screening ] [ Designated as safety issue: No ]
    • 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)

  • Incidence rate of persistent microscopic hematuria [ Time Frame: within 12 months ] [ Designated as safety issue: No ]
    • Among participants who had microscopic hematuria at the screening
    • Determined by repeated urine microscopy


Enrollment: 60048
Study Start Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Asymptomatic general population who underwent general health screening program

Criteria

Inclusion Criteria:

  • Age ≥ 20 years, male or female

Exclusion Criteria:

  • No result of urinalysis
  • No record of medical history (including medication)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01615315

Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Hospital
Seoul National University Bundang Hospital
Investigators
Principal Investigator: Sang Eun Lee, selee@snubh.org Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Sang Eun Lee, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01615315     History of Changes
Other Study ID Numbers: SNUBH-URO-2012-01
Study First Received: June 6, 2012
Last Updated: August 27, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
aspirin
screening
microscopic hematuria

Additional relevant MeSH terms:
Hematuria
Urination Disorders
Urologic Diseases
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013