Effect of Tranexamic Acid on Prevention of Recurrence of Hemoptysis

Seoul National University

Status and phase: Withdrawn; Phase 3

Conditions: Hemoptysis

Treatments: Drug: tranexamic acid, placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01167764

SNUH-tranexamic acid

Details and patient eligibility

About

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.

Sex: All

Ages: 25 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

tranexamic acid

Active Comparator group

Description:

tranexamic acid 250mg po 3 times/day for 1 months

Treatment:

Drug: tranexamic acid, placebo

placebo

Placebo Comparator group

Description:

placebo po 3 times/day for 1 months

Treatment:

Drug: tranexamic acid, placebo