The Role of Inhalations of Tranexamic Acid in Patients With Hemoptysis
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Status
Sponsors
Meir Medical Center
CLINICAL TRIAL: NCT01496196
BioSeek: NCT01496196
Keywords
Abstract
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.
Dates
| Last Verified: | 11/30/2011 |
| First Submitted: | 12/17/2011 |
| Estimated Enrollment Submitted: | 12/19/2011 |
| First Posted: | 12/20/2011 |
| Last Update Submitted: | 04/11/2015 |
| Last Update Posted: | 04/13/2015 |
| Actual Study Start Date: | 12/31/2011 |
| Estimated Primary Completion Date: | 12/31/2015 |
| Estimated Study Completion Date: | 01/31/2016 |
Condition or disease
Hemoptisis
Intervention/treatment
Drug: tranexamic acid-500 mg/5 ml 3-4 times a day
Drug: tranexamic
Phase
Phase 3
Arm Groups
| 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 500 mg/5 ml 3-4 times a day |
| Placebo Comparator: tranexamic placebo arm | Drug: tranexamic 500 mg/5 ml 3-4 times a day |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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 |
Outcome
Primary Outcome Measures
1. bleeding stops [1 year]
