A Phase 3 interventional study of nebulized tranexamic acid and Intravenous Tranexamic Acid in Hemoptysis and Pulmonary Hemorrhage, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by Assiut University · Phase 3, Interventional, and Treatment
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.
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.
37 studies on the registry are indexed under Hemoptysis; 6 are open to participants now.
This study's planned enrollment of 170 is above the median of 73 across 20 interventional studies indexed under Hemoptysis.
Browse Hemoptysis studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: nebulized tranexamic acid
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.
Drug: Intravenous Tranexamic Acid
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.
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.
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.
Time frame: Within 24 hours of treatment initiation
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
Time frame: 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.
Time frame: One month after initial bleeding control
No study locations are listed for this record.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Tranexamic Acid