Effect of Tranexamic Acid on Prevention of Recurrence of Hemoptysis
Phase 3
Withdrawn
- Conditions
- Hemoptysis
- Interventions
- Drug: tranexamic acid, placebo
- Registration Number
- NCT01167764
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Hemoptysis is one of the serious complication of many pulmonary diseases. Upto now, there is no proven medical treatment in recurrence of hemoptysis. The investigators will conduct a randomized, placebo controlled trial of tranexamic acid, which can reduce the recurrence of hemoptysis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- age: >=20 and <=75
- ER visit or admission for hemoptysis
- no evidence of hemoptysis on screening
Exclusion Criteria
- anticoagulation treatment
- Cr >= 2.0 mg/dL or urinary protein >= 2+ or who received renal replacement treatment
- hepatic failure: total bilirubin >= 1.5 mg/dL or AST or ALT >= 1.5 of upper normal limit level
- hypersensitivity to tranexamic acid
- pregnant woman
- fertile female who don't use contraception
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description tranexamic acid tranexamic acid, placebo tranexamic acid 250mg po 3 times/day for 1 months placebo tranexamic acid, placebo placebo po 3 times/day for 1 months
- Primary Outcome Measures
Name Time Method the proportion of recurrence of hemoptysis 6 month: 1months medication + 5months observation
- Secondary Outcome Measures
Name Time Method time to recurrence 6 month: 1months medication + 5months observation
Trial Locations
- Locations (3)
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Seoul Metropolitan Government Seoul National University Boramae Medical Center
🇰🇷Seoul, Korea, Republic of