Efficacy of Tranexamic Acid in Controlling Hemoptysis, A Randomized Control Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Change in severity of hemoptysis
研究概览
简要总结
The purpose of study is to evaluate the efficacy of tranexamic acid in controlling bleeding in patients of hemoptysis and also to evaluate the safety of tranexamic acid.
详细描述
Hemoptysis is a common problem in India due to high incidence of tuberculosis and also due to post tubercular sequale. Hemoptysis is usually managed conservatively in mild to moderate cases and cases of massive hemoptysis are managed with more definitive treatment options like vessel embolization (bronchial/pulmonary artery) and surgery as a last option. Tranexamic acid is a antifibrinolytic used in many surgeries and trauma patients to control bleeding and it has been shown effective and safe. The purpose of the study is to evaluate the efficacy of tranexamic acid in patients with hemoptysis in controlling bleeding.
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
- 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
- •Acute ongoing hemoptysis
- •Age: 18 years and above
排除标准
- •Pregnant females
- •Females on oral contraceptives
- •Patients on antifibrinolytics
- •Patients with known drug allergy
- •Patients with renal failure
- •Patients requiring intubation during study period
- •Patients with Massive hemoptysis (>600 ml/24 hrs)
研究组 & 干预措施
Tranexamic acid
All patients will receive basic resuscitative measures and standard treatment like assessment and management of Airway, breathing, circulation, antitussives, and blood products. Patients in group T will receive Inj Tranexamic acid in a loading dose of 1 g over 10 min followed by an infusion of 1 g over 8 h.
干预措施: Tranexamic Acid (Drug)
Placebo
All patients will receive basic resuscitative measures and standard treatment like assessment and management of Airway, breathing, circulation, antitussives, and blood products. Patients will receive 0.9% normal saline instead of Tranexamic acid.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in severity of hemoptysis
时间窗: day1 and day2
Frequency, amount, VAS score Objective assessment using VAS score at admission and at 48 hours.
次要结局
- Intervention needed(2 days)
- Blood transfusion needed(2 days)
- Hospital stay(Through study completion, an average of 1 year)
研究者
Balaji Laxminarayanshetty Bellam
junior resident
Post Graduate Institute of Medical Education and Research, Chandigarh