HemoptysisPhase 3NCT01167764
Effect of Tranexamic Acid on Prevention of Recurrence of Hemoptysis
A Phase 3 study of Hemoptysis, run by Seoul National University Hospital at 3 sites in South Korea.
Trial summary
Hemoptysis is one of the serious complication of many pulmonary diseases. Upto now, there is no proven medical treatment in recurrence of hemoptysis. The investigators will conduct a randomized, placebo controlled trial of tranexamic acid, which can reduce the recurrence of hemoptysis. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Hemoptysis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Jul 2011to Dec 2013
- 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age: >=20 and <=75
- ER visit or admission for hemoptysis
- no evidence of hemoptysis on screening
Who cannot join
- anticoagulation treatment
- Cr >= 2.0 mg/dL or urinary protein >= 2+ or who received renal replacement treatment
- hepatic failure: total bilirubin >= 1.5 mg/dL or AST or ALT >= 1.5 of upper normal limit level
- hypersensitivity to tranexamic acid
- pregnant woman
- fertile female who don't use contraception
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Seoul National University Bundang Hospital
Seongnam-si
Seoul National University Hospital
Seoul, 110-744
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul
About this study
Official title: Effect of Tranexamic Acid on Prevention of Recurrence of Hemoptysis: Multicenter, Prospective, Randomized, Double-blind Phase 3 Trial
Hemoptysis is one of the serious complication of many pulmonary diseases. Upto now, there is no proven medical treatment in recurrence of hemoptysis. The investigators will conduct a randomized, placebo controlled trial of tranexamic acid, which can reduce the recurrence of hemoptysis.
- Conditions
- Hemoptysis
- Being tested
- tranexamic acid, placebo
- Keywords
- hemoptysis, recurrence
- Medical subject headings
- Hemoptysis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tranexamic acid, placeboDrug
tranexamic acid 250mg tid for 1 months vs. placebo for 1 months
| Study group | Role | What they receive |
|---|---|---|
| tranexamic acid | Active comparator | tranexamic acid 250mg po 3 times/day for 1 months Receives: Drug: tranexamic acid, placebo |
| placebo | Placebo comparator | placebo po 3 times/day for 1 months Receives: Drug: tranexamic acid, placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportion of recurrence of hemoptysis
Measured: 6 month: 1months medication + 5months observation
Secondary outcomes (1)
time to recurrence
Measured: 6 month: 1months medication + 5months observation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2010 (estimated)
- Study startJul 2011
- Primary completionJul 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemoptysisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jae-Joon Yim, MD, PhD, Principal investigator, Seoul National University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01167764
- Sponsor's protocol ID
- SNUH-tranexamic acid
- Status last verified
- Jan 2014
- First submitted
- 21 Jul 2010
- Last updated
- 7 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tranexamic Acid on Prevention of Recurrence of Hemoptysis: Multicenter, Prospective, Randomized, Double-blind Phase 3 Trial
- ClinicalTrials.gov ID
- NCT01167764
- Acronym / sponsor ID
- SNUH-tranexamic acid
- Conditions
- Hemoptysis
- Keywords
- hemoptysis, recurrence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 22 Jul 2010 (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 one of the serious complication of many pulmonary diseases. Upto now, there is no proven medical treatment in recurrence of hemoptysis. The investigators will conduct a randomized, placebo controlled trial of tranexamic acid, which can reduce the recurrence of hemoptysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tranexamic acid | Active comparator | Drug: tranexamic acid, placebotranexamic acid 250mg po 3 times/day for 1 months |
| placebo | Placebo comparator | Drug: tranexamic acid, placeboplacebo po 3 times/day for 1 months |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age: >=20 and <=75
- ER visit or admission for hemoptysis
- no evidence of hemoptysis on screening
Key exclusion criteria (6 listed)
- anticoagulation treatment
- Cr >= 2.0 mg/dL or urinary protein >= 2+ or who received renal replacement treatment
- hepatic failure: total bilirubin >= 1.5 mg/dL or AST or ALT >= 1.5 of upper normal limit level
- hypersensitivity to tranexamic acid
- pregnant woman
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 acid, placebotranexamic acid 250mg tid for 1 months vs. placebo for 1 months | Drug | placebo, tranexamic acid |
Primary outcome
the proportion of recurrence of hemoptysis
Time frame: 6 month: 1months medication + 5months observation
1 secondary outcome
time to recurrence
Time frame: 6 month: 1months medication + 5months observation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2014.
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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.
Jae-Joon Yim, MD, PhD principal investigator
Seoul National University College of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Hemoptysis, run by Seoul National University Hospital at 3 sites in South Korea.
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 3 inclusion and 6 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: withdrawn, as of the sponsor's last update on 7 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the proportion of recurrence of hemoptysis (time frame: 6 month: 1months medication + 5months observation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jan 2014; AzTrials last refreshed its copy on 8 Nov 2026.