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Effect of Tranexamic Acid on Prevention of Recurrence of Hemoptysis

Primary Purpose

Hemoptysis

Status
Withdrawn
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
tranexamic acid, placebo
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hemoptysis focused on measuring hemoptysis, recurrence

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Seoul Metropolitan Government Seoul National University Boramae Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

tranexamic acid

placebo

Arm Description

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

placebo po 3 times/day for 1 months

Outcomes

Primary Outcome Measures

the proportion of recurrence of hemoptysis

Secondary Outcome Measures

time to recurrence

Full Information

First Posted
July 21, 2010
Last Updated
January 6, 2014
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01167764
Brief Title
Effect of Tranexamic Acid on Prevention of Recurrence of Hemoptysis
Official Title
Effect of Tranexamic Acid on Prevention of Recurrence of Hemoptysis: Multicenter, Prospective, Randomized, Double-blind Phase 3 Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Withdrawn
Study Start Date
July 2011 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemoptysis
Keywords
hemoptysis, recurrence

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tranexamic acid
Arm Type
Active Comparator
Arm Description
tranexamic acid 250mg po 3 times/day for 1 months
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo po 3 times/day for 1 months
Intervention Type
Drug
Intervention Name(s)
tranexamic acid, placebo
Intervention Description
tranexamic acid 250mg tid for 1 months vs. placebo for 1 months
Primary Outcome Measure Information:
Title
the proportion of recurrence of hemoptysis
Time Frame
6 month: 1months medication + 5months observation
Secondary Outcome Measure Information:
Title
time to recurrence
Time Frame
6 month: 1months medication + 5months observation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae-Joon Yim, MD, PhD
Organizational Affiliation
Seoul National University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Seoul Metropolitan Government Seoul National University Boramae Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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Effect of Tranexamic Acid on Prevention of Recurrence of Hemoptysis

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