[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643163":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":26,"responsibleParty":30,"collaborators":26,"id":34,"slug":35,"hasResults":36,"nctId":37,"briefTitle":38,"officialTitle":39,"acronym":26,"eligibilityCriteria":40,"healthyVolunteers":36,"sex":41,"minAge":42,"maxAge":26,"enrollmentInfo":43,"targetDuration":26,"studyType":46,"phases":47,"briefSummary":49,"conditions":50,"keywords":53,"overallStatus":59,"whyStopped":26,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":26},{"fullName":5,"class":6},"Assiut University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Nebulized Tranexamic Acid","EXPERIMENTAL","Patients in this group will receive tranexamic acid (500 mg\u002F5 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.",[13],"Drug: nebulized tranexamic acid",{"label":15,"type":16,"description":17,"interventionNames":18},"Intravenous Tranexamic Acid","ACTIVE_COMPARATOR","Patients in this group will receive tranexamic acid (500 mg\u002F5 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.",[19],"Drug: Intravenous Tranexamic Acid",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","nebulized tranexamic acid","Tranexamic acid 500 mg\u002F5ml administered via a standard jet nebulizer. The dose is repeated every 8 hours for up to 48 to 72 hours, or until bleeding cessation.",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Tranexamic acid 500 mg\u002F5 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.",[15],{"type":31,"investigatorFullName":32,"investigatorTitle":33,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Nehal Kamal Ahmed Abdelaal","Resident at Chest Department, Assiut University","100643163","phase-3-nebulized-versus-intravenous-tranexamic-acid-for-the-management-of-hemoptysis-100643163",false,"NCT07641946","Nebulized Versus Intravenous Tranexamic Acid for the Management of Hemoptysis","Nebulized Versus Intravenous Tranexamic Acid for the Management of Hemoptysis: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Age ≥18 years.\n* Presenting with active hemoptysis 24-48 hours prior to enrollment, or ongoing bleeding at presentation.\n* Patients presented with mild to moderate hemoptysis, defined as \\\u003C100 mL\u002Fday, or with clinically stable non-massive hemoptysis without evidence of respiratory or hemodynamic compromise.\n* Hemodynamically stable at presentation defined as systolic blood pressure ≥90 mmHg without vasopressor support, heart rate ≤120 beats\u002Fmin, and absence of clinical signs of shock or ongoing hemodynamic deterioration.\n* 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.\n* Written informed consent obtained from the patient.\n\nExclusion Criteria:\n\n* 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).\n* Hemodynamic instability which defined as SBP \\\u003C90 mmHg or MAP \\\u003C65 mmHg, need for vasopressor support, or clinical evidence of end-organ hypoperfusion or shock.\n* Respiratory failure requiring immediate invasive mechanical ventilation.\n* Patients known with hypersensitivity to tranexamic acid.\n* Patients receiving ongoing anticoagulant therapy that can interfere with the antifibrinolytic effect of tranexamic acid.\n* Patients with known bleeding disorders, severe coagulopathy, or thrombocytopenia (platelet count \\\u003C50,000\u002Fmm³).\n* Patients with severe renal impairment (e.g., estimated glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73 m² or requiring dialysis).\n* 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.\n* Pregnancy or lactation.","ALL","18 Years",{"count":44,"type":45},170,"ESTIMATED","INTERVENTIONAL",[48],"PHASE3","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.\n\nUsually, 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.\n\nTo 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:\n\nGroup 1: Will receive the tranexamic acid medication inhaled through a nebulizer mask.\n\nGroup 2: Will receive the tranexamic acid medication through a standard IV line.\n\nThe 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.",[51,52],"Hemoptysis","Pulmonary Hemorrhage",[54,9,15,55,56,57,58],"Tranexamic Acid","Antifibrinolytic Agents","Inhalational Therapy","Active Bleeding","Airway Management","NOT_YET_RECRUITING","2026-06-08",{"date":62,"type":63},"2026-06-11","ACTUAL",{"date":65,"type":45},"2026-07",{"date":67,"type":45},"2027-08",{"name":5,"class":6}]