Impact of Tranexamic Acid on Red Blood Cell Transfusion in Spinal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Percentage of patients transfusions
研究概览
简要总结
Spinal surgery may be associated with substantial blood loss which often requires erythrocyte transfusion. Transfusion of red blood cells (RBC) is not free of adverse events and has been associated with increased risks of infection, and globally higher morbidity and mortality.
Different techniques have been used to reduce perioperative blood losses and related transfusions. Tranexamic acid has been used successfully in cardiac and hepatic surgery. However, only a few studies have reported on the use of antifibrinolytic drugs in spinal surgery.
This study was designed to assess the efficacy and safety of tranexamic acid in spinal surgery for the reduction of RBC transfusion.
Hypothesis: the infusion of tranexamic acid during spinal surgery will reduce the risk of receiving a RBC transfusion and, in those patients transfused, reduce the number of blood products administered.
详细描述
Administration of study drug
The administration of tranexamic acid/placebo will start following the induction of general anesthesia. A bolus dose will be given intravenously over 30 minutes followed by a continuous infusion administered up to 6 hours postoperatively.
Drugs used for anesthesia and postoperative analgesia will be left to the discretion of the attending anesthesiologist. The administration of fluids (crystalloids, colloids and blood products) will be recorded.
Transfusion: The transfusion trigger will be < 80 g/L during surgery if the situation is stable. Transfusion may be initiated according to the attending anesthesiologist if the situation is unstable. In the case of massive bleeding, transfusion will follow our standard institutional protocol. The presence of microvascular bleeding at the surgical site will be assessed by the surgeon. The Cellsaver will not be used.
The transfusion trigger during the postoperative period will be < 80 g/L. Blood losses and the need for transfusion will be recorded from the moment of surgery up to 72 hours postoperatively.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 85 years
- •Patients undergoing spinal surgery with expected significant blood loss
- •American Society of Anesthesiologists physical status(ASA) I to III inclusive
排除标准
- •Allergy to tranexamic acid
- •Minimally invasive surgery
- •Unwillingness to receive blood transfusion
- •Known coagulopathy/hepatic disease
- •Previous thromboembolic events
- •Pregnancy
- •Renal impairment
研究组 & 干预措施
Tranexamic acid
Study subjects will be randomized to receive a bolus dose of 30 mg/kg of tranexamic acid administered over 30 minutes starting after the induction of anesthesia followed by a continuous intravenous infusion of tranexamic acid of 16 mg/kg/h administered up to 6 hours after surgery.
干预措施: Tranexamic Acid (Drug)
Normal saline (NaCl 0.9%)
Study subjects will be randomized to receive a bolus dose of normal saline (NaCl 0.9%) of equivalent volume administered over 30 minutes starting after the induction of anesthesia followed by a continuous intravenous infusion of NaCl 0.9% administered up to 6 hours after surgery.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of patients transfusions
时间窗: From surgery until 72 hours postoperatively
Number of red blood cell transfusions
时间窗: From surgery until 72 hours postoperatively
次要结局
- Length of stay in the hospital(At time of discharge)
- Calculated blood losses(From surgery until 72 hours postoperatively)
- Measured blood losses(From surgery until 72 hours postoperatively)
- Morbidity(From surgery until 30 days postoperatively)
- Mortality(From surgery until 30 days postoperatively)