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NCT07641946

PHASE3

Nebulized Versus Intravenous Tranexamic Acid for the Management of Hemoptysis

Sponsor: Assiut University

View on ClinicalTrials.gov

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. 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.

Official title: Nebulized Versus Intravenous Tranexamic Acid for the Management of Hemoptysis: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

170

Start Date

2026-07

Completion Date

2027-08

Last Updated

2026-06-11

Healthy Volunteers

Conditions

Hemoptysis Pulmonary Hemorrhage

Interventions

DRUG

nebulized 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.

DRUG

Intravenous Tranexamic Acid

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.

Inclusion Criteria: * 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. Exclusion Criteria: * 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). * 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.

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Nebulized Versus Intravenous Tranexamic Acid for the Management of Hemoptysis

Summary

Key Details

Conditions

Interventions

Eligibility Criteria