- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01496196
The Role of Inhalations of Tranexamic Acid in Patients With Hemoptysis
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.
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: David Shitrit, Dr.
- Phone Number: 09-7471556
- Email: Davids3@clalit.org.il
Study Locations
-
-
-
Kfar Saba, Israel, 972
- Recruiting
- Pulmonary department, Meir Medical Center
-
Contact:
- David Shitrit, Dr.
- Phone Number: 09-7471556
- Email: Davids3@clalit.org.il
-
Principal Investigator:
- David Shitrit, Dr.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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
|
500 mg/5 ml 3-4 times a day
|
Placebo Comparator: tranexamic
placebo arm
|
500 mg/5 ml 3-4 times a day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
bleeding stops
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David Shitrit, Dr., Meir Medical Center, Kfar Saba, Israel
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0096-11-MMC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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