Effect of Tranexamic Acid on Prevention of Recurrence of Hemoptysis

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01167764
First received: July 21, 2010
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Hemoptysis
Drug: tranexamic acid, placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • the proportion of recurrence of hemoptysis [ Time Frame: 6 month: 1months medication + 5months observation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • time to recurrence [ Time Frame: 6 month: 1months medication + 5months observation ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: July 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01167764

Locations
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
Principal Investigator: Jae-Joon Yim, MD, PhD Seoul National University College of Medicine
  More Information

No publications provided

Responsible Party: Jae-Joon Yim / Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01167764     History of Changes
Other Study ID Numbers: SNUH-tranexamic acid
Study First Received: July 21, 2010
Last Updated: January 6, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
hemoptysis
recurrence

Additional relevant MeSH terms:
Hemoptysis
Recurrence
Lung Diseases
Respiratory Tract Diseases
Hemorrhage
Pathologic Processes
Signs and Symptoms, Respiratory
Signs and Symptoms
Disease Attributes
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 18, 2014