The Role of Inhalations of Tranexamic Acid in Patients With Hemoptysis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Meir Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01496196
First received: December 18, 2011
Last updated: March 5, 2013
Last verified: December 2011
  Purpose

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 Intervention Phase
Hemoptisis
Drug: tranexamic acid
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • bleeding stops [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
  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: 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
  More Information

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01496196     History of Changes
Other Study ID Numbers: 0096-11-MMC
Study First Received: December 18, 2011
Last Updated: March 5, 2013
Health Authority: Israel: Ethics Commission

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
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014