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Aspirin and the Risk of Microscopic Hematuria in Asymptomatic Screened Population

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ClinicalTrials.gov Identifier: NCT01615315
Recruitment Status : Completed
First Posted : June 8, 2012
Last Update Posted : August 28, 2012
Sponsor:
Collaborator:
Seoul National University Bundang Hospital
Information provided by (Responsible Party):
Sang Eun Lee, Seoul National University Bundang Hospital

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.

Condition or disease
Asymptomatic General Population Microscopic Hematuria

Study Type : Observational
Actual Enrollment : 60048 participants
Observational Model: Cohort
Time Perspective: Retrospective
Study Start Date : August 2012
Actual Primary Completion Date : August 2012

Resource links provided by the National Library of Medicine

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




Primary Outcome Measures :
  1. Incidence rate of the microscopic hematuria [ Time Frame: at the screening ]
    >4 RBC/HPF in urine microscopy


Secondary Outcome Measures :
  1. 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)

  2. 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



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Ages Eligible for Study:   20 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: June 8, 2012    Key Record Dates
Last Update Posted: August 28, 2012
Last Verified: August 2012

Keywords provided by Sang Eun Lee, Seoul National University Bundang Hospital:
aspirin
screening
microscopic hematuria

Additional relevant MeSH terms:
Hematuria
Urination Disorders
Urologic Diseases
Hemorrhage
Pathologic Processes
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics