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临床试验/CTRI/2019/05/019337
CTRI/2019/05/019337招募中Unknown

Nebulized vs Intravenous tranexamic acid in patients withhemoptysis presenting to Emergency Department : A randomized controlstudy

AIIMS New Delhi1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年1月7日最近更新:

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

  1. Need for urgent interventional procedures – Bronchoscopy and bronchial artery embolization(BAE).

  2. 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).)

研究者

发起方
AIIMS New Delhi
申办方类型
Government medical college

研究点 (1)

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