The Role of Inhalations of Tranexamic Acid in Patients With Hemoptysis
NCT ID: NCT01496196
Last Updated: 2015-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
100 participants
INTERVENTIONAL
2012-01-31
2016-02-29
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
tranexamic acid
500 mg/5 ml 3-4 times a day
tranexamic
placebo arm
tranexamic acid
500 mg/5 ml 3-4 times a day
Interventions
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tranexamic acid
500 mg/5 ml 3-4 times a day
tranexamic acid
500 mg/5 ml 3-4 times a day
Eligibility Criteria
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Inclusion Criteria
* Hemodynamicaly stable
* Hemoptysis of varying etiologies
* Coumadin treatment will be switched to clexane or heparine
Exclusion Criteria
* 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
18 Years
90 Years
ALL
No
Sponsors
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Meir Medical Center
OTHER
Responsible Party
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Principal Investigators
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David Shitrit, Dr.
Role: PRINCIPAL_INVESTIGATOR
Meir Medical Center, Kfar Saba, Israel
Locations
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Pulmonary department, Meir Medical Center
Kfar Saba, Israel, Israel
Countries
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Central Contacts
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Facility Contacts
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References
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Wand O, Guber E, Guber A, Epstein Shochet G, Israeli-Shani L, Shitrit D. Inhaled Tranexamic Acid for Hemoptysis Treatment: A Randomized Controlled Trial. Chest. 2018 Dec;154(6):1379-1384. doi: 10.1016/j.chest.2018.09.026. Epub 2018 Oct 12.
Other Identifiers
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0096-11-MMC
Identifier Type: -
Identifier Source: org_study_id
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