Nebulized Versus Intravenous Tranexamic Acid for Hemoptysis
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssiut University
About this 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.
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
nebulized tranexamic acid
DrugTranexamic 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 Acid
DrugTranexamic 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.
Treatment groups
170 Participants
are divided into 2 treatment groupsGroup A: Nebulized Tranexamic AcidExperimental treatment 1 intervention
Group B: Intravenous Tranexamic AcidActive comparator 1 intervention
Trial outcomes
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.
Time frame
Within 24 hours of treatment initiationSecondary outcomes
1
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 initiation2
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 controlLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: