A Randomized, Parallel-group, Placebo Control, Non-inferiority Trial to Investigate the Safety of Intravenous Tranexamic Acid in Patients Undergoing Supratentorial Meningiomas Resection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- Early postoperative seizures within 7 days
研究概览
简要总结
Growing evidence of Tranexamic Acid (TXA) being used to reduce blood loss and blood transfusions in various guidelines. However, the adverse effects of TXA especially seizure has always been a problem of concern, especially in neurosurgery. Therefore, this study aims to provide a scientific evidence for the safety of TXA in supratentorial meningiomas resection 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-80 years
- •American Society of Anesthesiologist (ASA) classification score I~III
排除标准
- •allergic to tranexamic acid
- •preoperative seizures
- •history of thrombotic disease
- •chronic kidney disease
- •breastfeeding or pregnancy
- •refuse to participate in the study
研究组 & 干预措施
Placebo group
The TXA group will receives 0.9% saline intraoperative.
干预措施: 0.9% saline (Drug)
TXA group
The TXA group will receives Tranexamic acid intraoperative.
干预措施: Tranexamic acid (Drug)
结局指标
主要结局
Early postoperative seizures within 7 days
时间窗: Within 7 days after surgery
Postoperative seizures were defined as a transient occurrence of involuntary movements, abnormal sensory phenomena, or an altered mental status that could not otherwise be explained.
次要结局
- The intraoperative blood transfusion volume and rate(During surgery)
- The incidence of non-epileptic complications(Within 7 days after the intervention)
- Estimated intraoperative blood loss(During surgery)
- The intraoperative cell saver volume and rate(During surgery)
- The changes in haemoglobin concentrations(During surgery)
研究者
Yuming Peng
Deputy chief of Department of Anesthesiology
Beijing Tiantan Hospital