A Randomized Controlled Trial of Inhaled Tranexamic Acid for the Treatment of Pulmonary Hemorrhage in Cancer Patients
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 28 day all-cause mortality rate
研究概览
简要总结
This is a drug study that will examine if inhaled tranexamic acid can improve mortality in patients with cancer-related pulmonary hemorrhage and respiratory failure as compared to usual care.
详细描述
Primary Objective: To assess the benefit of using nebulized tranexamic acid versus the standard of care on 30 day mortality.
Secondary Objectives: To assess the following outcomes when using nebulized tranexamic acid versus the standard of care:
- 100 day, ICU and hospital mortality rate
- Ventilator days at day 30
- ICU and Hospital Length of Stay
- PaO2:FIO2 ratio (or SpO2:FIO2 ratio) changes over the first 14 days
- Time to resolution of pulmonary hemorrhage
- Rate of recurrence of pulmonary hemorrhage
- Rate of invasive procedures required to control pulmonary hemorrhage
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age > 18 years old
- •Have a diagnosed hematological malignancy
- •Are actively receiving mechanical ventilation
- •Have evidence of pulmonary hemorrhage as defined by either
- •Persistently bloody secretions upon endotracheal tube suctioning, or
- •Evidence of diffuse alveolar hemorrhage by bronchoscopic examination
- •Signed informed consent by patient or if the subject lacks decision-making capacity, the subject's legally authorized representative
排除标准
- •Patients excluded from participation in the study if any of the following criteria are met:
- •Presence of a Do Not Resuscitate (DNR), no escalation of care or comfort care order at the time of screening
- •Expected survival < 48 hours
- •Evidence of nasal or oral spillage likely to be the cause of bloody secretions
- •Patients requiring 100% FIO2
- •Known hypersensitivity to tranexamic acid
- •Treatment with inhaled tranexamic acid prior to screening
- •Acquired defective color vision
- •Subarachnoid hemorrhage
- •Deep Venous or arterial thrombus diagnosed within the previous 3 months
- •Seizure disorder on active anti-epileptic therapies
- •Hypersensitivity to tranexamic acid or any of the ingredients
- •Pregnant women will not be eligible and have a negative pregnancy test prior to entering study
- •Patient receiving concurrent anti-fibrinolytic therapy
- •Confirmed active COVID-19 infection
研究组 & 干预措施
Group B: Usual Care
usual care
干预措施: Usual Care (Other)
Group A: Inhaled tranexamic acid
will receive 500 mg/5ml nebulized tranexamic acid every 8 hours for at least 3 days, and up to 5 days
干预措施: tranexamic acid (Drug)
结局指标
主要结局
28 day all-cause mortality rate
时间窗: up to 28 days
Number of patients who are alive at 28 days following randomization. The difference between 28-day mortality rates between treatment arms will be computed along with a 95% confidence interval (CI) using the approximate standard error reported in Fleiss (1981). Logistic regression will be used to estimate the association between 28-day mortality and study covariates of interest.
次要结局
未报告次要终点