Nebulized vs Intravenous tranexamic acid in patients withhemoptysis presenting to Emergency Department : A randomized controlstudy
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Cessation of bleeding in patients presenting to ED with active
研究概览
简要总结
This study is a Parallel randomized (non- blinded) single-centered study and will be conducted at Emergency Department of All India Institute of Medical Sciences (AIIMS), New Delhi comparing the effects of nebulised vs intravenous tranexamic acid in patients with hemoptysis presenting to the emergency department. 25 patients will be recurited in each arm. The IV arm would receive 500 mg of tranexamic acid intravenously slowly over 15 mins followed by 500mg TA iv TDS and Neb. arm would receive 500mg(5ml) of nebulized TA mixed with 5 ml of distilled water stat followed by 500mg TA iv TDS . The osmolarity of TA is 680mOsm/Kg and when diluted with 5 ml of distilled water is 320mOsm/Kg, making iso-osmolar to plasma. The patients would be advised to collect hemoptysis in a measuring cup and the amount of bleed in 12 and 24 hours in both the arms would be collected.
All treatment decision will be taken by the treating physician, including need for intervention. The patients who undergo intervention would be treated as intention to treat analysis.The primary outcome is Cessation of bleeding in patients presenting to ED with active hemoptysis at 30 minutes after initiation of treatment. And secondary objectives are
-
Need for urgent interventional procedures – Bronchoscopy and bronchial artery embolization(BAE).
-
Reduction in volume of hemoptysis at 6, 12 and 24 hours after presenting to Emergency department(ED).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Adult(>18years) patients presenting to the Emergency Department with active hemoptysis.
排除标准
- •Patients already received tranexamic acid before presenting to the hospital.
- •Intubated patients on mechanical ventilation.
- •Patients with massive life-threatening hemoptysis who need to be immediately shifted for interventional procedures.
结局指标
主要结局
Cessation of bleeding in patients presenting to ED with active
时间窗: 30 minutes after initiation of treatment.
hemoptysis at 30 minutes after initiation of treatment.
时间窗: 30 minutes after initiation of treatment.
次要结局
- 1. Need for urgent(interventional procedures – Bronchoscopy and)
- 2. Reduction in volume of hemoptysis at 6, 12 and 24 hours after(presenting to Emergency department(ED).)
