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The Role of Inhalations of Tranexamic Acid in Patients With Hemoptysis

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ClinicalTrials.gov 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
Sponsor:
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

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

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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 ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT01496196


Contacts
Contact: David Shitrit, Dr. 09-7471556 Davids3@clalit.org.il

Locations
Israel
Pulmonary department, Meir Medical Center Recruiting
Kfar Saba, Israel, 972
Contact: David Shitrit, Dr.    09-7471556    Davids3@clalit.org.il   
Principal Investigator: David Shitrit, Dr.         
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: David Shitrit, Dr. Meir Medical Center, Kfar Saba, Israel

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01496196     History of Changes
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:
hemoptisis
bleeding
tranexamic acid

Additional relevant MeSH terms:
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants