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

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.

Study Overview

• Status: Withdrawn
• Conditions: Hemoptysis
• Intervention / Treatment: Drug: tranexamic acid, placebo

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seongnam-si, Korea, Republic of
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Seoul Metropolitan Government Seoul National University Boramae Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: tranexamic acid; tranexamic acid 250mg po 3 times/day for 1 months	Drug: tranexamic acid, placebo; tranexamic acid 250mg tid for 1 months vs. placebo for 1 months
PLACEBO_COMPARATOR: placebo; placebo po 3 times/day for 1 months	Drug: tranexamic acid, placebo; tranexamic acid 250mg tid for 1 months vs. placebo for 1 months

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Jae-Joon Yim, MD, PhD, Seoul National University College of Medicine

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (ANTICIPATED): July 1, 2013
• Study Completion (ANTICIPATED): December 1, 2013

Study Registration Dates

• First Submitted: July 21, 2010
• First Submitted That Met QC Criteria: July 21, 2010
• First Posted (ESTIMATE): July 22, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): January 7, 2014
• Last Update Submitted That Met QC Criteria: January 6, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: recurrence; hemoptysis
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Hemorrhage; Signs and Symptoms, Respiratory; Recurrence; Hemoptysis; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: SNUH-tranexamic acid