Effect of Tranexamic Acid on Prevention of Recurrence of Hemoptysis
1 other identifier
interventional
N/A
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2011
3 active sites
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
July 21, 2010
CompletedFirst Posted
Study publicly available on registry
July 22, 2010
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJanuary 7, 2014
January 1, 2014
2 years
July 21, 2010
January 6, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the proportion of recurrence of hemoptysis
6 month: 1months medication + 5months observation
Secondary Outcomes (1)
time to recurrence
6 month: 1months medication + 5months observation
Study Arms (2)
tranexamic acid
ACTIVE COMPARATORtranexamic acid 250mg po 3 times/day for 1 months
placebo
PLACEBO COMPARATORplacebo po 3 times/day for 1 months
Interventions
tranexamic acid 250mg tid for 1 months vs. placebo for 1 months
Eligibility Criteria
You may qualify if:
- age: \>=20 and \<=75
- ER visit or admission for hemoptysis
- no evidence of hemoptysis on screening
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Seoul National University Hospital
Seoul, 110-744, South Korea
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jae-Joon Yim, MD, PhD
Seoul National University College of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 21, 2010
First Posted
July 22, 2010
Study Start
July 1, 2011
Primary Completion
July 1, 2013
Study Completion
December 1, 2013
Last Updated
January 7, 2014
Record last verified: 2014-01