Nebulized Versus Intravenous Tranexamic Acid for Hemoptysis
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.
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- Phase 3
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Nebulized Tranexamic Acid
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.
|
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.
|
|
Comparateur actif: Intravenous 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.
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Proportion of Participants with Complete Cessation of Hemoptysis
Délai: 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.
|
Within 24 hours of treatment initiation
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Time to Complete Hemoptysis Control
Délai: Up to 72 hours after treatment initiation
|
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
|
Up to 72 hours after treatment initiation
|
|
Incidence of Hemoptysis Recurrence
Délai: One month after initial bleeding control
|
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.
|
One month after initial bleeding control
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- AUFM-CH-TXA-2026-001
Informations sur les médicaments et les dispositifs, documents d'étude
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