The Role of Inhalations of Tranexamic Acid in Patients With Hemoptysis
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2012
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2011
CompletedFirst Posted
Study publicly available on registry
December 21, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedApril 14, 2015
December 1, 2011
4 years
December 18, 2011
April 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
bleeding stops
1 year
Study Arms (2)
tranexamic acid-500 mg/5 ml 3-4 times a day
ACTIVE COMPARATORtranexamic acid arm: inhalations of tranexamic acid 500 mg/5 ml 3-4 times a day
tranexamic
PLACEBO COMPARATORplacebo arm
Interventions
Eligibility Criteria
You may qualify if:
- Age \> 18
- Hemodynamicaly stable
- Hemoptysis of varying etiologies
- Coumadin treatment will be switched to clexane or heparine
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pulmonary department, Meir Medical Center
Kfar Saba, Israel, 972, Israel
Related Publications (1)
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.
PMID: 30321510DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Shitrit, Dr.
Meir Medical Center, Kfar Saba, Israel
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2011
First Posted
December 21, 2011
Study Start
January 1, 2012
Primary Completion
January 1, 2016
Study Completion
February 1, 2016
Last Updated
April 14, 2015
Record last verified: 2011-12