HemoptysisPhase 4NCT07845747
Comparison Between Efficacy of Inhaled VS Intravenous Tranexamic Acid for Hemoptysis
A Phase 4 study testing Tranexamic Acid in people with Hemoptysis, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
This will be a prospective comparative cohort study and will take place at the Ward II- Ojha Institute of Chest Diseases (OICD) ,Dow University of Health Sciences in Karachi. It will be conducted over six months after obtaining necessary approvals. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hemoptysis
- What is being tested?
- Tranexamic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Sep 2026to 15 Feb 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients aged 18-60 years.
- Patients diagnosed with hemoptysis based on the defined operational definition.
- Patients who provide written informed consent to participate in the study.
Who cannot join
- Patients with known hypersensitivity to Tranexamic acid.
- Hemodynamically unstable patients.
- Patients requiring immediate interventional procedure or mechanical ventilation.
- Patients with active thromboembolic events (pulmonary embolism, deep vein thrombosis, ischemic stroke).
- Patients with a history of thromboembolic disease.
- Patients with disseminated intravascular coagulation (DIC) without heparin.
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- Patients with severe renal impairment, gross upper urinary tract hematuria, recent vascular stent/graft, or subarachnoid hemorrhage.
- Pregnant and breastfeeding women.
- Patients who are not willing to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Ward-2 Ojha Institute of Chest Diseases (OICD), Dow University of Health Sciences
Karachi, Sindh
About this study
This will be a prospective comparative cohort study and will take place at the Ward II- Ojha Institute of Chest Diseases (OICD) ,Dow University of Health Sciences in Karachi.
It will be conducted over six months after obtaining necessary approvals. We will recruit 154 patients aged 18-60 years, regardless of gender, who will present with complain of hemoptysis. Patients will be selected through a non-probability consecutive sampling method, where each eligible patient will be approached for participation.
Read more
Participants will be randomly assigned to one of two groups using a lottery method:
- Group A will receive 500 mg of inhaled Tranexamic acid three times a day.
- Group B will receive 500 mg of intravenous Tranexamic acid three times a day.
Once patients give consent for participation, we will gather detailed medical history. Blood tests and X-rays will be done to assess each patient's health status.
We will then monitor the amount of blood expectorated after 30 minutes, 6 hours, 12 hours, and 24 hours post-administration. We will also observe any side effects from the treatment.
- Conditions
- Hemoptysis
- Being tested
- 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 AcidDrug
Tranexamic acid 500 mg administered via inhaled route three times daily or intravenous route three times daily for management of hemoptysis
| Study group | Role | What they receive |
|---|---|---|
| Inhaled Tranexamic Acid | Experimental | Not described Receives: Drug: Tranexamic Acid |
| Intravenous Tranexamic Acid | Experimental | Not described Receives: Drug: Tranexamic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant reduction in hemoptysis
Proportion of patients achieving more than 50% reduction in hemoptysis blood volume after administration of Tranexamic Acid.
Measured: 2 hours after drug administration
Secondary outcomes (2)
Amount of hemoptysis reduction
Change in amount of blood loss due to hemoptysis after treatment.
Measured: 30 minutes, 6 hours, 12 hours, and 24 hours after drug administration
Side effects of Tranexamic Acid
Presence of adverse effects after administration of Tranexamic Acid, including redness, burning, pain, swelling, or other reported side effects.
Measured: Within 24 hours after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion15 Feb 2027 (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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07845747
- Sponsor's protocol ID
- IRB-4175/DUHS/APPROVAL/2025
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Efficacy of Inhaled VS Intravenous Tranexamic Acid for Hemoptysis
- ClinicalTrials.gov ID
- NCT07845747
- Acronym / sponsor ID
- IRB-4175/DUHS/APPROVAL/2025
- Conditions
- Hemoptysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 29 Sep 2026 (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 will be a prospective comparative cohort study and will take place at the Ward II- Ojha Institute of Chest Diseases (OICD) ,Dow University of Health Sciences in Karachi.
It will be conducted over six months after obtaining necessary approvals. We will recruit 154 patients aged 18-60 years, regardless of gender, who will present with complain of hemoptysis. Patients will be selected through a non-probability consecutive sampling method, where each eligible patient will be approached for participation.
Participants will be randomly assigned to one of two groups using a lottery method:
- Group A will receive 500 mg of inhaled Tranexamic acid three times a day.
- Group B will receive 500 mg of intravenous Tranexamic acid three times a day.
Once patients give consent for participation, we will gather detailed medical history. Blood tests and X-rays will be done to assess each patient's health status.
We will then monitor the amount of blood expectorated after 30 minutes, 6 hours, 12 hours, and 24 hours post-administration. We will also observe any side effects from the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhaled Tranexamic Acid | Experimental | Drug: Tranexamic Acid |
| Intravenous Tranexamic Acid | Experimental | Drug: Tranexamic Acid |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult patients aged 18-60 years.
- Patients diagnosed with hemoptysis based on the defined operational definition.
- Patients who provide written informed consent to participate in the study.
Key exclusion criteria (9 listed)
- Patients with known hypersensitivity to Tranexamic acid.
- Hemodynamically unstable patients.
- Patients requiring immediate interventional procedure or mechanical ventilation.
- Patients with active thromboembolic events (pulmonary embolism, deep vein thrombosis, ischemic stroke).
- Patients with a history of thromboembolic disease.
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 AcidTranexamic acid 500 mg administered via inhaled route three times daily or intravenous route three times daily for management of hemoptysis | Drug | Inhaled Tranexamic Acid, Intravenous Tranexamic Acid |
Primary outcome
Significant reduction in hemoptysis
Time frame: 2 hours after drug administration
Proportion of patients achieving more than 50% reduction in hemoptysis blood volume after administration of Tranexamic Acid.
2 secondary outcomes
Amount of hemoptysis reduction
Time frame: 30 minutes, 6 hours, 12 hours, and 24 hours after drug administration
Side effects of Tranexamic Acid
Time frame: Within 24 hours after drug administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
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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.
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 4 study testing Tranexamic Acid in people with Hemoptysis, run by Dow University of Health Sciences 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 9 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: enrolling by invitation, as of the sponsor's last update on 29 Sep 2026. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Significant reduction in hemoptysis (time frame: 2 hours after drug administration). 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 29 Sep 2026.