Tranexamic Acid in Major Vascular Surgery. A Randomized Placebo-controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Blood loss (milliliters)
研究概览
简要总结
The purpose of this study is to determine whether tranexamic acid is effective in reducing intraoperative blood loss and necessity for haemotransfusion in patients undergoing open abdominal aortic aneurysm repair
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 50
- •Able to give written informed consent
- •Undergoing open abdominal aortic aneurysm repair
排除标准
- •Patients participating in a pharmaceutical clinical trial in the last 3 months
- •Urgent/emergent surgery
- •Allergy/intolerance to tranexamic acid
- •History of seizures
- •Acute Venous or Arterial Thrombosis
- •Fibrinolytic conditions due to consumption coagulopathy
- •Disseminated intravascular coagulation
- •Haematuria
- •Visual disturbances
研究组 & 干预措施
Placebo
Saline
干预措施: Placebo (Drug)
Tranexamic Acid
A 500 mg loading dose of tranexamic acid diluted in 100 ml of saline solution will be slowly administered intravenously to patients 20 minutes before surgery, followed by a continuos infusion of 250 mg/h of tranexamic acid from surgical incision until skin closure.
干预措施: tranexamic acid diluted in 100 ml of saline solution (loading dose) (Drug)
Tranexamic Acid
A 500 mg loading dose of tranexamic acid diluted in 100 ml of saline solution will be slowly administered intravenously to patients 20 minutes before surgery, followed by a continuos infusion of 250 mg/h of tranexamic acid from surgical incision until skin closure.
干预措施: tranexamic acid undiluted (continous infusion) (Drug)
结局指标
主要结局
Blood loss (milliliters)
时间窗: intraoperative (from skin incision to skin closure)
次要结局
- Mortality(28-days and one year after surgery)
- Number of packed blood red cells transfused(hospital stay (an average of one week))
- Occurrence of thromboembolic events (of any nature)(28-days and one year after surgery)
研究者
Laura Pasin
Medical Doctor
IRCCS San Raffaele