Aspirin and the Risk of Microscopic Hematuria in Asymptomatic Screened Population

Microscopic Hematuria Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01615315
• Other study ID #: SNUBH-URO-2012-01
• Status: Completed
• Phase: N/A
• First received: June 6, 2012
• Last updated: August 27, 2012
• Start date: August 2012

Study information

• Verified date: August 2012
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60048
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 89 Years

Eligibility

Inclusion Criteria:

• Age = 20 years, male or female

Exclusion Criteria:

• No result of urinalysis

• No record of medical history (including medication)

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Asymptomatic General Population
• Hematuria
• Microscopic Hematuria

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of the microscopic hematuria	>4 RBC/HPF in urine microscopy	at the screening	No
Secondary	Detection rate of significant cause for microscopic hematuria	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; urinary stone; renal mass (benign or malignant / not simple cyst); urothelial cancer; other lesions (clinically relevant lesions determined by researchers)	whitin 12 months after screening	No
Secondary	Incidence rate of persistent microscopic hematuria	Among participants who had microscopic hematuria at the screening; Determined by repeated urine microscopy	within 12 months	No