HemoptysisPhase 3NCT07641946
Nebulized Versus Intravenous Tranexamic Acid for Hemoptysis
A Phase 3 study testing nebulized tranexamic acid and Intravenous Tranexamic Acid in people with Hemoptysis and Pulmonary Hemorrhage, run by Assiut University.
Trial summary
This clinical trial aims to compare two different ways of giving a medication called tranexamic acid to patients who are coughing up blood (a condition known as hemoptysis). Coughing up blood can be a serious medical issue that needs to be stopped quickly. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemoptysis, Pulmonary Hemorrhage
- What is being tested?
- nebulized tranexamic acid and Intravenous Tranexamic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Aug 2027
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Presenting with active hemoptysis 24-48 hours prior to enrollment, or ongoing bleeding at presentation.
- Patients presented with mild to moderate hemoptysis, defined as <100 mL/day, or with clinically stable non-massive hemoptysis without evidence of respiratory or hemodynamic compromise.
- Hemodynamically stable at presentation defined as systolic blood pressure ≥90 mmHg without vasopressor support, heart rate ≤120 beats/min, and absence of clinical signs of shock or ongoing hemodynamic deterioration.
- Patients able to maintain a patent airway, tolerate nebulized therapy, and have no immediate contraindications (e.g., severe bronchospasm, impaired consciousness with aspiration risk, or need for urgent intubation), ensuring safe and effective drug delivery.
- Written informed consent obtained from the patient.
Who cannot join
- Massive or life-threatening hemoptysis defined as expectoration of >100 mL of blood within 24 hours, or any volume associated with impaired gas exchange, airway obstruction, or hemodynamic instability requiring urgent intervention (e.g., bronchoscopy, bronchial artery embolization, endotracheal intubation, or surgery).
- Hemodynamic instability which defined as SBP <90 mmHg or MAP <65 mmHg, need for vasopressor support, or clinical evidence of end-organ hypoperfusion or shock.
- Respiratory failure requiring immediate invasive mechanical ventilation.
- Patients known with hypersensitivity to tranexamic acid.
- Patients receiving ongoing anticoagulant therapy that can interfere with the antifibrinolytic effect of tranexamic acid.
- Patients with known bleeding disorders, severe coagulopathy, or thrombocytopenia (platelet count <50,000/mm³).
Show all 9Show fewer
- Patients with severe renal impairment (e.g., estimated glomerular filtration rate <30 mL/min/1.73 m² or requiring dialysis).
- Patients with active thromboembolic disease or a recent history (within the past 3-6 months) of deep vein thrombosis, pulmonary embolism, ischemic stroke, or myocardial infarction.
- Pregnancy or lactation.
About this study
Official title: Nebulized Versus Intravenous Tranexamic Acid for the Management of Hemoptysis: A Randomized Controlled Trial
This clinical trial aims to compare two different ways of giving a medication called tranexamic acid to patients who are coughing up blood (a condition known as hemoptysis). Coughing up blood can be a serious medical issue that needs to be stopped quickly. Tranexamic acid is a well-known medication that helps blood to clot and stops bleeding.
Usually, this medication is given through an intravenous (IV) line directly into a vein. However, doctors are now studying if giving the medication through a breathing mask (nebulizer) might work just as well or better. A nebulizer changes the liquid medicine into a fine mist so the patient can breathe it directly into their lungs, targeting the exact area where the bleeding is happening.
Read more
To find out which method is better, researchers will randomly assign 170 adult patients who come to the hospital coughing up blood into two equal groups:
Group 1: Will receive the tranexamic acid medication inhaled through a nebulizer mask.
Group 2: Will receive the tranexamic acid medication through a standard IV line.
The main goal of the study is to see which treatment is more successful at completely stopping the bleeding within 24 hours. Researchers will also closely monitor the patients to see how quickly the bleeding stops, how long patients need to stay in the hospital, and if there are any side effects from either treatment method.
Read the detailed description
Hemoptysis is a frequent and potentially life-threatening clinical emergency, often attributed to conditions like post-tuberculous bronchiectasis and lung malignancy, which represent a substantial local disease burden. While traditional management includes supportive care and invasive procedures such as bronchial artery embolization, these interventions are not always readily available and carry inherent risks. Tranexamic acid (TXA), an antifibrinolytic agent, is a promising adjunctive therapy. While intravenous administration is traditional, it has demonstrated variable efficacy and carries potential systemic adverse effects. Recently, nebulized TXA has gained attention for its ability to deliver high local drug concentrations directly to the bleeding site while minimizing systemic exposure. Despite emerging evidence supporting the safety and efficacy of inhaled TXA, direct comparative evidence between the nebulized and intravenous routes remains limited.
This trial is conducted at the Chest Department of Assiut University Hospitals. Patients presenting to the emergency department with active hemoptysis will undergo comprehensive baseline assessments using a standardized case-record form. This will capture demographic data, smoking history, and relevant medical history (e.g., tuberculosis, bronchiectasis, COPD, malignancy, anticoagulant use). Initial clinical evaluations include monitoring vital signs to confirm hemodynamic stability. Baseline laboratory investigations will consist of a complete blood count, coagulation profile (PT, INR, aPTT), renal and liver function tests, and blood grouping. All patients will also undergo appropriate chest imaging, including radiography and computed tomography (CT/CTPA), to identify the underlying source of bleeding. Bronchoscopy will be utilized when clinically indicated.
Following randomization and initiation of therapy, patients will be monitored closely. To objectively quantify blood loss, patients will be provided with 100 mL transparent measuring cups with 10 mL markings. Patients will be instructed to expectorate into these cups, which will be replaced and assessed every 8 hours. Furthermore, patient-reported severity of bleeding will be evaluated using a 10-cm Visual Analogue Scale (VAS) at baseline, 24 hours, and 48 hours post-treatment initiation.
Safety protocols dictate that if a patient's hemoglobin level falls below 10 g/dL, drops by 2 g/dL within a 72-hour period, or if bleeding fails to decrease with 8-hourly doses of TXA, the treating physician will consider escalation to invasive procedures.
Following discharge, participants will be followed for one month via outpatient clinic visits or telephone contact to assess for hemoptysis recurrence, hospital readmission, or delayed need for embolization/bronchoscopy.
- Conditions
- Hemoptysis, Pulmonary Hemorrhage
- Being tested
- nebulized tranexamic acid, Intravenous Tranexamic Acid
- Keywords
- Tranexamic Acid, Nebulized Tranexamic Acid, Intravenous Tranexamic Acid, Antifibrinolytic Agents, Inhalational Therapy, Active Bleeding, Airway Management
- Medical subject headings
- Hemoptysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nebulized tranexamic acidDrug
Tranexamic acid 500 mg/5ml administered via a standard jet nebulizer. The dose is repeated every 8 hours for up to 48 to 72 hours, or until bleeding cessation.
Intravenous Tranexamic AcidDrug
Tranexamic acid 500 mg/5 ml administered slowly intravenously over 10 minutes. The dose is repeated every 8 hours for up to 48 to 72 hours, or until bleeding cessation.
| Study group | Role | What they receive |
|---|---|---|
| Nebulized Tranexamic Acid | Experimental | Patients in this group will receive tranexamic acid (500 mg/5 ml) administered via a standard jet nebulizer. The dose will be repeated every 8 hours for up to 48 to 72 hours, or until the cessation of bleeding. This intervention is administered in addition to standard supportive management. Receives: Drug: nebulized tranexamic acid |
| Intravenous Tranexamic Acid | Active comparator | Patients in this group will receive tranexamic acid (500 mg/5 ml) administered intravenously slowly over 10 minutes. The dose will be repeated every 8 hours for up to 48 to 72 hours, or until the cessation of bleeding. This intervention is administered in addition to standard supportive management. Receives: Drug: Intravenous Tranexamic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants with Complete Cessation of Hemoptysis
This measure evaluates the efficacy of the treatment by tracking the complete absence of visible blood in the participant's expectorated sputum. To ensure objective assessment, patients collect expectorated blood in 100 ml transparent measuring cups with 10 ml markings. These cups are replaced and assessed every 8 hours. Success is strictly defined as no visible blood expectoration for at least 24 consecutive hours after the intervention.
Measured: Within 24 hours of treatment initiation
Secondary outcomes (2)
Time to Complete Hemoptysis Control
The duration measured in hours from the administration of the first dose of the assigned tranexamic acid treatment until the complete cessation of visible blood in expectorated sputum
Measured: Up to 72 hours after treatment initiation
Incidence of Hemoptysis Recurrence
The number of participants who experience a return of hemoptysis after achieving initial control and subsequent hospital discharge. This will be assessed through scheduled outpatient follow-up visits or telephone contact.
Measured: One month after initial bleeding control
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionAug 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.
- More trials run by Assiut UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nehal Kamal Ahmed Abdelaal, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07641946
- Sponsor's protocol ID
- AUFM-CH-TXA-2026-001
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nebulized Versus Intravenous Tranexamic Acid for the Management of Hemoptysis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07641946
- Acronym / sponsor ID
- AUFM-CH-TXA-2026-001
- Conditions
- Hemoptysis, Pulmonary Hemorrhage
- Keywords
- Tranexamic Acid, Nebulized Tranexamic Acid, Intravenous Tranexamic Acid, Antifibrinolytic Agents, Inhalational Therapy, Active Bleeding, Airway Management
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 11 Jun 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 clinical trial aims to compare two different ways of giving a medication called tranexamic acid to patients who are coughing up blood (a condition known as hemoptysis). Coughing up blood can be a serious medical issue that needs to be stopped quickly. Tranexamic acid is a well-known medication that helps blood to clot and stops bleeding.
Usually, this medication is given through an intravenous (IV) line directly into a vein. However, doctors are now studying if giving the medication through a breathing mask (nebulizer) might work just as well or better. A nebulizer changes the liquid medicine into a fine mist so the patient can breathe it directly into their lungs, targeting the exact area where the bleeding is happening.
To find out which method is better, researchers will randomly assign 170 adult patients who come to the hospital coughing up blood into two equal groups:
Group 1: Will receive the tranexamic acid medication inhaled through a nebulizer mask.
Group 2: Will receive the tranexamic acid medication through a standard IV line.
The main goal of the study is to see which treatment is more successful at completely stopping the bleeding within 24 hours. Researchers will also closely monitor the patients to see how quickly the bleeding stops, how long patients need to stay in the hospital, and if there are any side effects from either treatment method.
Detailed description
Hemoptysis is a frequent and potentially life-threatening clinical emergency, often attributed to conditions like post-tuberculous bronchiectasis and lung malignancy, which represent a substantial local disease burden. While traditional management includes supportive care and invasive procedures such as bronchial artery embolization, these interventions are not always readily available and carry inherent risks. Tranexamic acid (TXA), an antifibrinolytic agent, is a promising adjunctive therapy. While intravenous administration is traditional, it has demonstrated variable efficacy and carries potential systemic adverse effects. Recently, nebulized TXA has gained attention for its ability to deliver high local drug concentrations directly to the bleeding site while minimizing systemic exposure. Despite emerging evidence supporting the safety and efficacy of inhaled TXA, direct comparative evidence between the nebulized and intravenous routes remains limited.
This trial is conducted at the Chest Department of Assiut University Hospitals. Patients presenting to the emergency department with active hemoptysis will undergo comprehensive baseline assessments using a standardized case-record form. This will capture demographic data, smoking history, and relevant medical history (e.g., tuberculosis, bronchiectasis, COPD, malignancy, anticoagulant use). Initial clinical evaluations include monitoring vital signs to confirm hemodynamic stability. Baseline laboratory investigations will consist of a complete blood count, coagulation profile (PT, INR, aPTT), renal and liver function tests, and blood grouping. All patients will also undergo appropriate chest imaging, including radiography and computed tomography (CT/CTPA), to identify the underlying source of bleeding. Bronchoscopy will be utilized when clinically indicated.
Following randomization and initiation of therapy, patients will be monitored closely. To objectively quantify blood loss, patients will be provided with 100 mL transparent measuring cups with 10 mL markings. Patients will be instructed to expectorate into these cups, which will be replaced and assessed every 8 hours. Furthermore, patient-reported severity of bleeding will be evaluated using a 10-cm Visual Analogue Scale (VAS) at baseline, 24 hours, and 48 hours post-treatment initiation.
Safety protocols dictate that if a patient's hemoglobin level falls below 10 g/dL, drops by 2 g/dL within a 72-hour period, or if bleeding fails to decrease with 8-hourly doses of TXA, the treating physician will consider escalation to invasive procedures.
Following discharge, participants will be followed for one month via outpatient clinic visits or telephone contact to assess for hemoptysis recurrence, hospital readmission, or delayed need for embolization/bronchoscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nebulized Tranexamic Acid | Experimental | Drug: nebulized tranexamic acidPatients in this group will receive tranexamic acid (500 mg/5 ml) administered via a standard jet nebulizer. The dose will be repeated every 8 hours for up to 48 to 72 hours, or until the cessation of bleeding. This intervention is administered in addition to standard supportive management. |
| Intravenous Tranexamic Acid | Active comparator | Drug: Intravenous Tranexamic AcidPatients in this group will receive tranexamic acid (500 mg/5 ml) administered intravenously slowly over 10 minutes. The dose will be repeated every 8 hours for up to 48 to 72 hours, or until the cessation of bleeding. This intervention is administered in addition to standard supportive management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years.
- Presenting with active hemoptysis 24-48 hours prior to enrollment, or ongoing bleeding at presentation.
- Patients presented with mild to moderate hemoptysis, defined as <100 mL/day, or with clinically stable non-massive hemoptysis without evidence of respiratory or hemodynamic compromise.
- Hemodynamically stable at presentation defined as systolic blood pressure ≥90 mmHg without vasopressor support, heart rate ≤120 beats/min, and absence of clinical signs of shock or ongoing hemodynamic deterioration.
- Patients able to maintain a patent airway, tolerate nebulized therapy, and have no immediate contraindications (e.g., severe bronchospasm, impaired consciousness with aspiration risk, or need for urgent intubation), ensuring safe and effective drug delivery.
Key exclusion criteria (9 listed)
- Massive or life-threatening hemoptysis defined as expectoration of >100 mL of blood within 24 hours, or any volume associated with impaired gas exchange, airway obstruction, or hemodynamic instability requiring urgent intervention (e.g., bronchoscopy, bronchial artery embolization, endotracheal intubation, or surgery).
- Hemodynamic instability which defined as SBP <90 mmHg or MAP <65 mmHg, need for vasopressor support, or clinical evidence of end-organ hypoperfusion or shock.
- Respiratory failure requiring immediate invasive mechanical ventilation.
- Patients known with hypersensitivity to tranexamic acid.
- Patients receiving ongoing anticoagulant therapy that can interfere with the antifibrinolytic effect of tranexamic acid.
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 |
|---|---|---|
| nebulized tranexamic acidTranexamic acid 500 mg/5ml administered via a standard jet nebulizer. The dose is repeated every 8 hours for up to 48 to 72 hours, or until bleeding cessation. | Drug | Nebulized Tranexamic Acid |
| Intravenous Tranexamic AcidTranexamic acid 500 mg/5 ml administered slowly intravenously over 10 minutes. The dose is repeated every 8 hours for up to 48 to 72 hours, or until bleeding cessation. | Drug | Intravenous Tranexamic Acid |
Primary outcome
Proportion of Participants with Complete Cessation of Hemoptysis
Time frame: Within 24 hours of treatment initiation
This measure evaluates the efficacy of the treatment by tracking the complete absence of visible blood in the participant's expectorated sputum. To ensure objective assessment, patients collect expectorated blood in 100 ml transparent measuring cups with 10 ml markings. These cups are replaced and assessed every 8 hours. Success is strictly defined as no visible blood expectoration for at least 24 consecutive hours after the intervention.
2 secondary outcomes
Time to Complete Hemoptysis Control
Time frame: Up to 72 hours after treatment initiation
Incidence of Hemoptysis Recurrence
Time frame: One month after initial bleeding control
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 14 Jul 2026.
Related trials for Hemoptysis
Not yet recruitingObservational study
Chinese Hemoptysis Registry Study
Hemoptysis
Enrolling by invitationPhase 4
Comparison Between Efficacy of Inhaled VS Intravenous Tranexamic Acid for Hemoptysis
Hemoptysis
RecruitingObservational study
Tracheal Cuff Pressure and Postoperative Complications
Tracheal Intubation, Postoperative Complications (Cardiopulmonary)
Not yet recruitingObservational study
HISTOACRYL® Used for Embolization of Thoracoabdominal Artery Bleeding
Hemorrhage, Gastrointestinal Hemorrhage
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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing nebulized tranexamic acid and Intravenous Tranexamic Acid in people with Hemoptysis and Pulmonary Hemorrhage, run by Assiut University.
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 6 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: opening soon, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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 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?
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?
Proportion of Participants with Complete Cessation of Hemoptysis (time frame: Within 24 hours of treatment initiation). 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 14 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.