Efficacy of nebulized tranexamic acid in improving yield during endobronchial biopsies.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- Efficacy of nebulized tranexamic acid in increasing the adequacy of endobronchial biopsy.
研究概览
简要总结
Tranexamic acid is an antifibrinolytic agent that can be used to prevent the dissolution of fibrin clots. Recent studies have shown that using nebulized tranexamic acid would reduce hemoptysis in patients who presented to emergency. Bleeding is one of the well recognized complications of conventional endobronchial biopsies that could be sometimes life-threatening and would result in the reduced yield of the biopsy sample. The current study aims at studying the use of nebulized tranexamic acid in increasing the yield and controlling bleeding during endobronchial biopsy procedure
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients aged ≥18 years posted for fiberoptic bronchoscopy with a plan for obtaining endobronchial biopsy.
排除标准
- •Active and ongoing pulmonary bleeding (haemoptysis), 2) Known history of bleeding predisposition, 3) Decompensated liver disease, 4) Kidney disease (an estimated glomerular filtration rate of ≤30 ml/min), 5) Known allergy to tranexamic acid.
结局指标
主要结局
Efficacy of nebulized tranexamic acid in increasing the adequacy of endobronchial biopsy.
时间窗: Adequate sample will be | defined as biopsy sample sufficient for histopathology, immunohistochemistry, and molecular | analysis.
次要结局
- To assess the efficacy to control bleeding during endobronchial biopsy.(Severity of bleeding: Mild: requiring continuous suctioning and bleeding stopped)
- To assess the procedure length.(Length of the procedure from nebulization with study agent to end of the procedure.)
- To assess the number and size of biopsies obtained.(Number of biopsies will be determined based upon successful passes taken and size will be)
- To assess the safety of nebulized tranexamic acid just prior to endobronchial biopsy.(Incidence and frequency all adverse events and SAEs will be reported as per the CTCAE)
研究者
Vineela Surapaneni
Pandit B.D Sharma, PGIMS, Rohtak