Effect of Tranexamic Acid on Intraoperative Blood Loss in Patients Undergoing Brain Meningioma Resections: Study Protocol of a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- Estimated intra-operative blood loss
研究概览
简要总结
Intra-operative blood loss of huge meningioma resection patients on average was over 1000ml. Intra-operative massive hemorrhage was associated with longer hospital of stay, higher expense, and higher mortality. Previous studies indicated intra-operative tranexamic acid infusion would decrease blood loss for cardiac, trauma and obstetric procedures. However, limited researches focusing on the effect of tranexamic acid in neurosurgery population, with heterogenous pathologies. The purpose of this study was to investigate the effect of tranexamic acid on intra-operative blood loss in patients undergoing huge meningioma resection.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective supratentorial meningioma resection with estimated tumor diameter >5cm on brain image.
- •Age between 18-65 years.
- •American Society of Anaesthesiologist (ASA) physical status Ⅰ to Ⅲ
- •Obtain written informed consent.
排除标准
- •Allergic to tranexamic acid.
- •History of thrombotic disease.
- •History of chronic kidney disease
- •Receiving other anticoagulation or antiplatelet treatment.
- •Refuse to provide written informed consent
研究组 & 干预措施
Continous infusion group
Infusion with 20mg/kg tranexamic acid and 5mg/kg/h tranexamic acid.
干预措施: Continous infusion (Drug)
Single infusion group
Infusion with 20mg/kg tranexamic acid and same volume 0.9% saline.
干预措施: Single infusion (Drug)
Placebo group
Infusion with same volume of 0.9% saline.
干预措施: Placebo (Drug)
结局指标
主要结局
Estimated intra-operative blood loss
时间窗: During surgery
Estimated intra-operative blood loss is assessed as following formula:collected blood volume in the suction canister (mL) - the volume of flushing (mL) + the volume from gauze tampon (mL).
次要结局
未报告次要终点
研究者
Shu Li
Associate Clinical Professor
Beijing Tiantan Hospital