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Effect of Tranexamic Acid on Prevention of Recurrence of Hemoptysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01167764
Recruitment Status : Withdrawn
First Posted : July 22, 2010
Last Update Posted : January 7, 2014
Sponsor:
Information provided by:
Seoul National University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hemoptysis Drug: tranexamic acid, placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Tranexamic Acid on Prevention of Recurrence of Hemoptysis: Multicenter, Prospective, Randomized, Double-blind Phase 3 Trial
Study Start Date : July 2011
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : December 2013

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. the proportion of recurrence of hemoptysis [ Time Frame: 6 month: 1months medication + 5months observation ]

Secondary Outcome Measures :
  1. time to recurrence [ Time Frame: 6 month: 1months medication + 5months observation ]

Eligibility Criteria
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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01167764


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Jae-Joon Yim, MD, PhD Seoul National University College of Medicine
More Information
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Responsible Party: Jae-Joon Yim / Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01167764    
Other Study ID Numbers: SNUH-tranexamic acid
First Posted: July 22, 2010    Key Record Dates
Last Update Posted: January 7, 2014
Last Verified: January 2014
Keywords provided by Seoul National University Hospital:
hemoptysis
recurrence
Additional relevant MeSH terms:
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Hemoptysis
Recurrence
Disease Attributes
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Hemorrhage
 Signs and Symptoms, Respiratory
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants