HemoptisisPhase 3NCT01496196
The Role of Inhalations of Tranexamic Acid in Patients With Hemoptysis
A Phase 3 study testing tranexamic acid in people with Hemoptisis, run by Meir Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hemoptisis
- What is being tested?
- tranexamic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2012to Feb 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18
- Hemodynamicaly stable
- Hemoptysis of varying etiologies
- Coumadin treatment will be switched to clexane or heparine
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Pulmonary department, Meir Medical Center
Kfar Saba, Israel, 972
David Shitrit, Dr., 09-7471556, Davids3@clalit.org.il
David Shitrit, Dr.
About this study
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.
- Conditions
- Hemoptisis
- Being tested
- tranexamic acid
- Keywords
- hemoptisis, bleeding, tranexamic acid
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tranexamic acidDrug
500 mg/5 ml 3-4 times a day
tranexamic acidDrug
500 mg/5 ml 3-4 times a day
| Study group | Role | What they receive |
|---|---|---|
| tranexamic acid-500 mg/5 ml 3-4 times a day | Active comparator | tranexamic acid arm: inhalations of tranexamic acid 500 mg/5 ml 3-4 times a day Receives: Drug: tranexamic acid |
| tranexamic | Placebo comparator | placebo arm Receives: Drug: tranexamic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
bleeding stops
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionJan 2016 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemoptisisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Shitrit, Dr., Principal investigator, Meir Medical Center, Kfar Saba, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01496196
- Sponsor's protocol ID
- 0096-11-MMC
- Status last verified
- Dec 2011
- First submitted
- 18 Dec 2011
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30321510
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Inhalations of Tranexamic Acid in Patients With Hemoptysis
- ClinicalTrials.gov ID
- NCT01496196
- Acronym / sponsor ID
- 0096-11-MMC
- Conditions
- Hemoptisis
- Keywords
- hemoptisis, bleeding, tranexamic acid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 21 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tranexamic acid-500 mg/5 ml 3-4 times a day | Active comparator | Drug: tranexamic acidtranexamic acid arm: inhalations of tranexamic acid 500 mg/5 ml 3-4 times a day |
| tranexamic | Placebo comparator | Drug: tranexamic acidplacebo arm |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18
- Hemodynamicaly stable
- Hemoptysis of varying etiologies
- Coumadin treatment will be switched to clexane or heparine
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tranexamic acid500 mg/5 ml 3-4 times a day | Drug | tranexamic acid-500 mg/5 ml 3-4 times a day |
| tranexamic acid500 mg/5 ml 3-4 times a day | Drug | tranexamic |
Primary outcome
bleeding stops
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2015.
- Derived from this study: PubMed 30321510Wand 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Shitrit, Dr. principal investigator
Meir Medical Center, Kfar Saba, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tranexamic acid in people with Hemoptisis, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Shitrit, Dr. (09-7471556, Davids3@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bleeding stops (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01496196, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2015.