Could Early Tranexamic Acid Safely Serve as an Anti-inflammatory Treatment for Patients With Sepsis? A Randomized Double Blind Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- ICU mortality
研究概览
简要总结
In this study, our aim is to investigate the role tranexamic acid in modulating inflammation in patients with sepsis.
详细描述
A written informed consent will be taken from the patients or their relatives.Patients will be assigned randomly to two groups (40 subjects each) with qSOFA ≥2.
In (Group T) administer 1 gram of tranexamic acid (TXA) in 100 ml of 0.9% normal saline, intravenous over 10 minutes as soon as possible but no later than three hours after diagnosis, infuse a second gram of tranexamic acid (TXA) IV over 8 hours in 0.9% normal saline for the first 3 days. In (Group C) administer the same volume (100 ml normal saline)and same duration (first three days)for controlled patients.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (age 18-65 years) of American society of anesthesiologists (ASA) I-II who will be diagnosed with sepsis by qSOFA ≥2
- •& needed ICU admission.
排除标准
- •Chronic renal failure
- •Liver cirrhosis
- •Bleeding disorders or current anticoagulant therapy
- •Pregnancy or breastfeeding
- •Impaired color vision
- •Severe vascular ischemia, history of venous thrombosis & pulmonary embolism
- •Long term treatment with acetylsalicylic acid or non-steroidal anti-inflammatory drugs not discontinued before ICU admission
- •Allergy to tranexamic acid (TXA)
研究组 & 干预措施
Tranexamic acid
Give 1 gram of TXA in 100 ml of 0.9% normal saline, intravenous over 10 minutes as soon as possible but no later than three hours after diagnosis, infuse a second gram of TXA IV over 8 hours in 0.9% normal saline for the first 3 days.
干预措施: Tranexamic acid (Drug)
Saline placebo
Give the same volume (100 ml normal saline) and same duration (first three days).
干预措施: 0.9% saline (Other)
结局指标
主要结局
ICU mortality
时间窗: 7days
Short-term ICU mortality within 7days of admission and intervention
次要结局
- ICU stay(7 days)
- Glasgow coma scale (GCS)(5 days)
- Neutrophil/lymphocyte ratio (NLR)(4 days)
- Interleukin-6 (IL-6) serum level(4 days)
- Length of hospitalization(7 days)
研究者
Omar Makram Soliman
Lecturer of anesthesia and ICU
Assiut University