Tranexamic Acid Use for Bleeding Prevention in the Surgical Treatment of Metastatic Spinal Tumor in Lung Cancer Patients: a Triple Blinded, Randomized Controlled Trial to Assess the Efficacy of Tranexamic Acid for Hemostasis
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- total blood loss
研究概览
简要总结
Massive blood loss occurs in metastatic spinal tumor resection and may cause severe complications. The objective of this study is to investigate whether the use of tranexamic acid will reduce perioperative and postoperative bleeding when compared to those without use of tranexamic acid.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as metastatic carcinoma of the thoracolumbar spine
- •solitary neoplasm involve only one segment of spine
- •patients underwent separation surgery
排除标准
- •coagulation function was abnormal preoperatively
- •patients are allergic to tranexamic acid
- •neoplasm involve more than one segment of spine
- •patients with rich blood supply who need embolization
研究组 & 干预措施
tranexamic acid group
injection of 2 bottles of tranexamic acid (1g/bottle) before making incision; tranexamic acid soaked gauze applied to the wound before closing the wound; Intravenous injection of tranexamic acid 3 times (every 8 hours）within 24 hours after operation；
干预措施: Tranexamic Acid (Drug)
SPSS group
injection of 2 bottles of stroke-physiological saline solution（SPSS）before making incision; SPSS soaked gauze applied to the wound before closing the wound; Intravenous injection of SPSS 3 times (every 8 hours）within 24 hours after operation；
干预措施: stroke-physiological saline solution (SPSS) (Drug)
结局指标
主要结局
total blood loss
时间窗: measured 3 days postoperatively
the loss of total blood volume caused by various operations (mainly during surgical operations) throughout the entire treatment process. Total blood volume = preoperative blood volume \*（preoperative hematocrit - hematocrit 3 days postoperatively）
Intraoperative blood loss
时间窗: 1 day (measured once after surgery)
Refers to the total blood loss of a patient experienced during operation from skin incision to wound suture. Intraoperative blood loss = intraoperative drainage volume - intraoperative flushing volume + blood loss estimation using gauze (calculated as 10 cm × 10 cm gauze absorbs 10 ml)
次要结局
- allogeneic transfusion blood volume(1 day (measured once during surgery))