Effect of Tranexamic Acid on Prevention of Recurrence of Hemoptysis

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

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01167764

Enrollment

Registered

2010-07-22

Start date

2011-07-31

Completion date

2013-12-31

Last updated

2014-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemoptysis

Keywords

hemoptysis, recurrence

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.

Interventions

DRUGtranexamic acid, placebo

tranexamic acid 250mg tid for 1 months vs. placebo for 1 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

25 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
the proportion of recurrence of hemoptysis	6 month: 1months medication + 5months observation

Secondary

Measure	Time frame
time to recurrence	6 month: 1months medication + 5months observation

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026