Comparison Between Efficacy of Inhaled VS Intravenous Tranexamic Acid for Hemoptysis
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Significant reduction in hemoptysis
研究概览
简要总结
This will be a prospective comparative cohort study and will take place at the Ward II- Ojha Institute of Chest Diseases (OICD) ,Dow University of Health Sciences in Karachi.
It will be conducted over six months after obtaining necessary approvals. We will recruit 154 patients aged 18-60 years, regardless of gender, who will present with complain of hemoptysis. Patients will be selected through a non-probability consecutive sampling method, where each eligible patient will be approached for participation.
Participants will be randomly assigned to one of two groups using a lottery method:
- Group A will receive 500 mg of inhaled Tranexamic acid three times a day.
- Group B will receive 500 mg of intravenous Tranexamic acid three times a day.
Once patients give consent for participation, we will gather detailed medical history. Blood tests and X-rays will be done to assess each patient's health status.
We will then monitor the amount of blood expectorated after 30 minutes, 6 hours, 12 hours, and 24 hours post-administration. We will also observe any side effects from the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 18-60 years.
- •Patients diagnosed with hemoptysis based on the defined operational definition.
- •Patients who provide written informed consent to participate in the study.
排除标准
- •Patients with known hypersensitivity to Tranexamic acid.
- •Hemodynamically unstable patients.
- •Patients requiring immediate interventional procedure or mechanical ventilation.
- •Patients with active thromboembolic events (pulmonary embolism, deep vein thrombosis, ischemic stroke).
- •Patients with a history of thromboembolic disease.
- •Patients with disseminated intravascular coagulation (DIC) without heparin.
- •Patients with severe renal impairment, gross upper urinary tract hematuria, recent vascular stent/graft, or subarachnoid hemorrhage.
- •Pregnant and breastfeeding women.
- •Patients who are not willing to participate in the study.
研究组 & 干预措施
Inhaled Tranexamic Acid
干预措施: Tranexamic Acid (Drug)
Intravenous Tranexamic Acid
干预措施: Tranexamic Acid (Drug)
结局指标
主要结局
Significant reduction in hemoptysis
时间窗: 2 hours after drug administration
Proportion of patients achieving more than 50% reduction in hemoptysis blood volume after administration of Tranexamic Acid.
次要结局
- Amount of hemoptysis reduction(30 minutes, 6 hours, 12 hours, and 24 hours after drug administration)
- Side effects of Tranexamic Acid(Within 24 hours after drug administration)