COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu
Trial record 1 of 1 for:    NCT01496196
Previous Study | Return to List | Next Study

The Role of Inhalations of Tranexamic Acid in Patients With 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. Identifier: NCT01496196
Recruitment Status : Unknown
Verified December 2011 by Meir Medical Center.
Recruitment status was:  Recruiting
First Posted : December 21, 2011
Last Update Posted : April 14, 2015
Information provided by (Responsible Party):
Meir Medical Center

Brief Summary:

Hemoptysis is defined as the expectoration of blood from respiratory tract, a spectrum that varies from blood-streaking of sputum to coughing up large amounts of pure blood.

Massive hemoptysis variably defined as the expectoration of 100-600 ml over 24-h period.

The most common site of bleeding is the tracheobronchial tree, which can be affected by inflammation (acute or chronic bronchitis, bronchiectasis) or by neoplasm ( bronchogenic carcinoma, endobronchial metastatic carcinoma, bronchial carcinoid tumor). The bronchial arteries, which originate either from aorta or from intercostal arteries, and are part of the high-pressure systemic circulation, are the source of bleeding in bronchitis or bronchiectasis or endo bronchial tumors.

Condition or disease Intervention/treatment Phase
Hemoptisis Drug: tranexamic acid Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : January 2012
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: tranexamic acid-500 mg/5 ml 3-4 times a day
tranexamic acid arm: inhalations of tranexamic acid 500 mg/5 ml 3-4 times a day
Drug: tranexamic acid
500 mg/5 ml 3-4 times a day

Placebo Comparator: tranexamic
placebo arm
Drug: tranexamic acid
500 mg/5 ml 3-4 times a day

Primary Outcome Measures :
  1. bleeding stops [ Time Frame: 1 year ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age > 18
  • Hemodynamicaly stable
  • Hemoptysis of varying etiologies
  • Coumadin treatment will be switched to clexane or heparine

Exclusion Criteria:

  • Age < 18
  • Hemodinamicaly unstable
  • Massive hemoptysis ( > 200 ml / day)
  • Renal failure: creatinine > 3, renal replacement treatment
  • Hepatic failure: bilirubin > 2 mg/dl, AST > 3 of upper normal limit level
  • Coagulation disorders, INR> 2.
  • Hypesensitivity to tranexamic acid
  • Pregnant woman

Information from the National Library of Medicine

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 identifier (NCT number): NCT01496196

Layout table for location contacts
Contact: David Shitrit, Dr. 09-7471556

Layout table for location information
Pulmonary department, Meir Medical Center Recruiting
Kfar Saba, Israel, 972
Contact: David Shitrit, Dr.    09-7471556   
Principal Investigator: David Shitrit, Dr.         
Sponsors and Collaborators
Meir Medical Center
Layout table for investigator information
Principal Investigator: David Shitrit, Dr. Meir Medical Center, Kfar Saba, Israel

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Meir Medical Center Identifier: NCT01496196    
Other Study ID Numbers: 0096-11-MMC
First Posted: December 21, 2011    Key Record Dates
Last Update Posted: April 14, 2015
Last Verified: December 2011
Keywords provided by Meir Medical Center:
tranexamic acid
Additional relevant MeSH terms:
Layout table for MeSH terms
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action