Nebulized Versus Intravenous Tranexamic Acid for the Management of Hemoptysis: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 170
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Intravenous Tranexamic Acid (Drug)
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.
干预措施: nebulized tranexamic acid (Drug)
研究者
Nehal Kamal Ahmed Abdelaal
Principal Investigator
Assiut University