Effect of Tranexamic Acid on Prevention of Recurrence of Hemoptysis

Hemoptysis Clinical Trial

Official title:

Effect of Tranexamic Acid on Prevention of Recurrence of Hemoptysis: Multicenter, Prospective, Randomized, Double-blind Phase 3 Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01167764
• Other study ID #: SNUH-tranexamic acid
• Status: Withdrawn
• Phase: Phase 3
• First received: July 21, 2010
• Last updated: January 6, 2014
• Start date: July 2011
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hemoptysis
• Recurrence

Intervention

Drug:
• tranexamic acid, placebo
tranexamic acid 250mg tid for 1 months vs. placebo for 1 months

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si
Korea, Republic of	Seoul Metropolitan Government Seoul National University Boramae Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the proportion of recurrence of hemoptysis		6 month: 1months medication + 5months observation	Yes
Secondary	time to recurrence		6 month: 1months medication + 5months observation	Yes