HemoptysisPhase 2/3NCT07212452
Tranexamic Acid : Nebulization vs IV Route for Hemoptysis
A Phase 2/3 study testing Tranexamic Acid (TXA) in people with Hemoptysis and NEBULIZATION, run by University of Health Sciences Lahore at 1 site in Pakistan.
Trial summary
This study compares the effect of tranexamic acid on hemoptysis when given through the conventional IV route and Through nebulization. Read more about this study
- Who is it for?
- Ages 12 to 80 years
- Conditions the study is for
- Hemoptysis, NEBULIZATION, Tranexamic Acid
- What is being tested?
- Tranexamic Acid (TXA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2025to 31 Oct 2025
- Phase
- Phase 2/3
- 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 12 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with mild to moderate hemoptysis < 600ml/ 24 hours of age 12 to 80 years and both genders.
- Patients with hemoptysis due to infective pathology.
- Patients with hemoptysis due to malignant pathology.
Who cannot join
- Patients on antiplatelet therapy or aspirin
- Hemoptysis after penetrating lung injury e.g. firearm injury
- Patients with history of asthma
Trial locations and contacts
1 site in 1 country.
About this study
This study compares the effect of tranexamic acid on hemoptysis when given through the conventional IV route and Through nebulization.
Read the detailed description
The investigators are conducting a randomized controlled trial for the comparison of routes through which tranexamic acid can be given to control hemoptysis. The study participants will be divided into 2 groups randomly and 1 group will be assigned to use IV route while other will be assigned the nebulization route and the result variables include the time taken for complete control of hemoptysis and recurrence time. Another variable is the reduction in amout of blood in sputum after each intervention.
- Conditions
- Hemoptysis, NEBULIZATION, Tranexamic Acid
- Being tested
- Tranexamic Acid (TXA)
- Keywords
- Hemoptysis, Nebulization, tranexamic acid
- Medical subject headings
- Hemoptysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid (TXA)Drug
Also called nebulization
In this study we are comparing the effect of tranexamic acid on hemoptysis when given through IV route and nebulization
| Study group | Role | What they receive |
|---|---|---|
| Group receiving tranexamic acid via IV route | Active comparator | Tranexamic acid has been used conventionally for hemoptysis via IV route Receives: Drug: Tranexamic Acid (TXA) |
| The Group receiving tranexamic acid via nebulization | Experimental | Tranexamic acid when given through nebulization can be more effective than IV route in controlling hemoptysis Receives: Drug: Tranexamic Acid (TXA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to control hemoptysis
In this study the time taken by tranexamic acid to acehive comolete control of hemoptysis will be compared when given through IV and nebulization.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start1 Aug 2025
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
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 HemoptysisStudies of the same condition, open and under way.
- More trials run by University of Health Sciences LahoreThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention will be given to the participants via providing the tranexamic acide through both IV and nebulization routes.
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laiba Qamar, University of Health Sciences Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07212452
- Sponsor's protocol ID
- #NTranexamic#
- Status last verified
- Sep 2025
- First submitted
- 30 Sep 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gopinath B, Mishra PR, Aggarwal P, Nayaka R, Naik SR, Kappagantu V, Shrimal P, Ramaswami A, Bhoi S, Jamshed N, Sinha TP, Ekka M, Kumar A. Nebulized vs IV Tranexamic Acid for Hemoptysis: A Pilot Randomized Controlled Trial. Chest. 2023 May;163(5):1176-1184. doi: 10.1016/j.chest.2022.11.021. Epub 2022 Nov 19.
PubMed 36410494
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid : Nebulization vs IV Route for Hemoptysis
- ClinicalTrials.gov ID
- NCT07212452
- Acronym / sponsor ID
- #NTranexamic#
- Conditions
- Hemoptysis, NEBULIZATION, Tranexamic Acid
- Keywords
- Hemoptysis, Nebulization, tranexamic acid
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- University of Health Sciences LahoreUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 8 Oct 2025 (actual)
- 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.
This study compares the effect of tranexamic acid on hemoptysis when given through the conventional IV route and Through nebulization.
Detailed description
The investigators are conducting a randomized controlled trial for the comparison of routes through which tranexamic acid can be given to control hemoptysis. The study participants will be divided into 2 groups randomly and 1 group will be assigned to use IV route while other will be assigned the nebulization route and the result variables include the time taken for complete control of hemoptysis and recurrence time. Another variable is the reduction in amout of blood in sputum after each intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention will be given to the participants via providing the tranexamic acide through both IV and nebulization routes.
| Arm | Type | Receives |
|---|---|---|
| Group receiving tranexamic acid via IV route | Active comparator | Drug: Tranexamic Acid (TXA)Tranexamic acid has been used conventionally for hemoptysis via IV route |
| The Group receiving tranexamic acid via nebulization | Experimental | Drug: Tranexamic Acid (TXA)Tranexamic acid when given through nebulization can be more effective than IV route in controlling hemoptysis |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with mild to moderate hemoptysis < 600ml/ 24 hours of age 12 to 80 years and both genders.
- Patients with hemoptysis due to infective pathology.
- Patients with hemoptysis due to malignant pathology.
Key exclusion criteria (3 listed)
- Patients on antiplatelet therapy or aspirin
- Hemoptysis after penetrating lung injury e.g. firearm injury
- Patients with history of asthma
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 (TXA)Also: nebulizationIn this study we are comparing the effect of tranexamic acid on hemoptysis when given through IV route and nebulization | Drug | Group receiving tranexamic acid via IV route, The Group receiving tranexamic acid via nebulization |
Primary outcome
Time to control hemoptysis
Time frame: 48 hours
In this study the time taken by tranexamic acid to acehive comolete control of hemoptysis will be compared when given through IV and nebulization.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Results publication: PubMed 36410494Gopinath B, Mishra PR, Aggarwal P, Nayaka R, Naik SR, Kappagantu V, Shrimal P, Ramaswami A, Bhoi S, Jamshed N, Sinha TP, Ekka M, Kumar A. Nebulized vs IV Tranexamic Acid for Hemoptysis: A Pilot Randomized Controlled Trial. Chest. 2023 May;163(5):1176-1184. doi: 10.1016/j.chest.2022.11.021. Epub 2022 Nov 19.
- The sample article is available through this linkLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tranexamic Acid (TXA) in people with Hemoptysis and NEBULIZATION, run by University of Health Sciences Lahore at 1 site in Pakistan.
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 3 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: finished, as of the sponsor's last update on 28 Nov 2025. 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 Pakistan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to control hemoptysis (time frame: 48 hours). 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 NCT07212452, 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 28 Nov 2025; AzTrials last refreshed its copy on 2 Nov 2026.