Single Dose Enteral Tranexamic Acid for the Reduction of Morbidity in Hospitalized Critically Ill Patients
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Morbidity
研究概览
简要总结
The premise of this study is that enteral tranexamic acid will help to maintain small bowel integrity, which is often compromised by critical illness due to inadequate cardiovascular perfusion (i.e., shock), and that maintenance of small bowel integrity will decrease morbidity in critically ill patients.
详细描述
The primary objective of this study is to provide preliminary efficacy and safety data on the enteral administration of a one-time dose of tranexamic acid to critically ill patients for the reduction of morbidity at 28 days after enrollment in the study.
Secondary objectives of this study are to determine the efficacy of administration of enteral tranexamic acid in reducing intensive care unit (ICU) and hospital length-of-stay, as well and mortality and morbidity at 6 months.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Critically ill patients admitted to ICU within 48 hours of onset of illness
- •Patients with feeding tubes (e.g., orogastric, nasogastric, PEG, etc.)
排除标准
- •primary admitting diagnosis of cancer
- •primary admitting diagnosis of acute congestive heart failure
- •primary admitting diagnosis of chronic obstructive pulmonary disease (COPD)
- •primary admitting diagnosis of acute myocardial infarction or unstable cardiac arrythmia
- •primary admitting diagnosis of amyotrophic lateral sclerosis (ALS) or other non-infectious disease
- •primary admitting diagnosis of post-operative neurosurgical procedure
- •known hypersensitivity to tranexamic acid
- •acquired disturbances of color vision
- •hematuria cause by disease of the renal parenchyma
- •active thromboembolic disease such as deep venous thrombosis or pulmonary embolism
- •patients with known clotting disorders or other known bleeding disorders
- •recent (within 3 months) or active cerebrovascular bleed
- •pregnancy
- •inability to take study medicine (i.e., ileus with > 500ml stomach residuals, NPO status)
- •patients excluded at the discretion of the treating physician
研究组 & 干预措施
Tranexamic acid
Study group receives enteral tranexamic acid in normal saline in addition to usual care.
干预措施: Tranexamic Acid (Drug)
Control group
Control group receives vehicle (normal saline) without study drug and usual care.
干预措施: Control Intervention (Carrier fluid only) (Drug)
结局指标
主要结局
Morbidity
时间窗: 28 days
Morbidity will be assessed at 28 days as measured by the validated Self-Administered Quality of Well-being Scale (QWB-SA) and 5-Point modified Oxford Handicap Scale \[secondary scale\]
次要结局
- mortality(6 months)
- ICU length of stay(up to 6 months)
- Hospital length of stay(up to 6 months)
- morbidity(6 months)
研究者
Erik B. Kistler, MD, PhD
Principal Investigator, Assistant Professor
San Diego Veterans Healthcare System