Nebulized Versus Intravenous Tranexamic Acid for the Management of Hemoptysis

NCT07641946 | Not Yet Recruiting Phase 3

• 1 other identifier: Nebulized vs IV TXA Hemoptysis
• Study Type: interventional
• Target: 170
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hemoptysis; Pulmonary Hemorrhage

Keywords

Tranexamic Acid; Nebulized Tranexamic Acid; Intravenous Tranexamic Acid; Antifibrinolytic Agents; Inhalational Therapy; Active Bleeding; Airway Management

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 24 hours of treatment initiation

Secondary Outcomes (2)

• Time to Complete Hemoptysis Control

  Up to 72 hours after treatment initiation

• Incidence of Hemoptysis Recurrence

  One month after initial bleeding control

Study Arms (2)

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.

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.

Drug: Intravenous Tranexamic Acid

Interventions

nebulized tranexamic acid DRUG

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.

Nebulized Tranexamic Acid

Intravenous Tranexamic Acid DRUG

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.

Intravenous Tranexamic Acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Hemoptysis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at Chest Department, Assiut University

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 11, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: June 11, 2026

Record last verified: 2026-06