A Comparison Between the Efficacy of Tranexamic Acid and Adrenaline to Control Endobronchial Bleeding - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Immediate Hemostasis (Bleeding Cessation)
研究概览
简要总结
During bronchoscopy (a procedure using a thin, flexible camera to look inside the airways), doctors sometimes take small tissue samples (biopsies) to diagnose lung conditions. This can cause bleeding in the airway. Doctors currently use a medicine called adrenaline to stop this bleeding, but it doesn't always work, and bleeding can come back afterward. Another medicine, tranexamic acid, may work better because it helps blood clot and stay clotted, rather than just narrowing the blood vessels.
This study compared tranexamic acid and adrenaline, both given directly onto the bleeding site through the bronchoscope, in patients who developed moderate bleeding after a biopsy. The goal was to find out which medicine stopped the bleeding better right away, and which one was less likely to let the bleeding start again within 30 minutes.
详细描述
This was a randomized controlled trial conducted at the Department of Pulmonology, Shaikh Zayed Hospital, Federal Postgraduate Medical Institute, Lahore, Pakistan, over a 12-month period. Adult patients undergoing diagnostic flexible bronchoscopy with endobronchial forceps biopsy who developed moderate post-biopsy bleeding (bleeding that obscured the bronchoscopic view and required repeated suctioning and endoscopic intervention, but without hemodynamic instability) were randomized by lottery method into two equal groups (n=38 each).
Group A received topical endobronchial adrenaline (1 mg diluted in 20 mL normal saline; 0.05 mg/mL), and Group B received topical endobronchial tranexamic acid (500 mg diluted in 20 mL normal saline; 25 mg/mL). The assigned drug was instilled directly onto the bleeding site through the bronchoscope's working channel in 5 mL aliquots, with administration repeated up to three times at 30-second intervals if bleeding persisted.
The primary outcome was immediate hemostasis, defined as cessation of oozing and/or formation of a stable clot within 90 seconds of drug instillation. The secondary outcome was rebleeding within 30 minutes of initial hemostasis, assessed by repeat bronchoscopic inspection. If bleeding persisted beyond 90 seconds despite maximal drug administration, this was classified as treatment failure, and rescue measures (cold saline, crossover drug instillation, wedge tamponade, electrocautery, or argon plasma coagulation) were used.
Demographic and clinical data (age, gender, BMI, smoking status, symptom duration, diabetes, hypertension) were recorded, and stratified subgroup analyses were performed. Statistical analysis used the Chi-square test for intergroup comparisons, with p≤0.05 considered significant.
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
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients of any age and gender undergoing diagnostic flexible bronchoscopy for suspected benign or malignant airway disease
- •Required endobronchial forceps biopsy during the procedure
- •Developed moderate endobronchial bleeding following biopsy (defined as bleeding that obscured the bronchoscopic view, required repeated suctioning to clear the airway, and required endoscopic intervention for hemostasis, but remained hemodynamically stable)
排除标准
- •Severe bleeding (requiring instillation of ice-cold saline, bronchoscopic tamponade, electrocautery, or argon plasma coagulation)
- •Life-threatening bleeding (requiring endotracheal intubation, or spontaneous hemoptysis of more than 100-150 mL per hour)
- •Contraindications to bronchoscopy, including:
- •Cardiac arrhythmias
- •Oxygen saturation below 90% on supplemental oxygen
- •Acute respiratory failure with hypercapnia
- •Tracheal obstruction
- •Bleeding diathesis with raised INR or platelet count less than 50,000/mm³
- •Unstable coronary artery disease
- •Hypersensitivity to tranexamic acid or adrenaline
研究组 & 干预措施
Adrenaline Group
Patients who developed moderate endobronchial bleeding after forceps biopsy received topical endobronchial adrenaline (1 mg diluted in 20 mL normal saline; concentration 0.05 mg/mL), instilled onto the bleeding site through the bronchoscope's working channel in 5 mL aliquots, repeated up to three times at 30-second intervals if bleeding persisted.
干预措施: Adrenaline (Drug)
Tranexamic Acid Group
Patients who developed moderate endobronchial bleeding after forceps biopsy received topical endobronchial tranexamic acid (500 mg diluted in 20 mL normal saline; concentration 25 mg/mL), instilled onto the bleeding site through the bronchoscope's working channel in 5 mL aliquots, repeated up to three times at 30-second intervals if bleeding persisted.
干预措施: Tranexamic Acid (Drug)
结局指标
主要结局
Immediate Hemostasis (Bleeding Cessation)
时间窗: Within 90 seconds of drug instillation
Immediate bleeding control, defined as direct bronchoscopic observation of cessation of oozing and/or formation of a stable clot at the bleeding site, assessed within 90 seconds of drug instillation. If bleeding persisted beyond 90 seconds despite maximal drug administration (up to 3 applications), this was classified as treatment failure and rescue hemostatic measures were initiated.
次要结局
- Rebleeding(Within 30 minutes of initial hemostasis)
研究者
Talha Mahmud
Professor Dr. Talha Mahmud
Sheikh Zayed Federal Postgraduate Medical Institute