Protective Effect of Tranexamic Acid on Shedding of the Endothelial Glycocalyx in Patients Undergoing Spinal Fusion Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- blood concentration of syndecan-1, heparan sulfate at the end of the surgery
研究概览
简要总结
The aim of this study was to determine whether the administration of tranexamic acid in patients undergoing lumbar spinal fusion surgery can inhibit damage in endothelial glycocalyx layer. As a prospective double blinded randomized placebo-controlled trial, the investigators detect and compare the changes in concentrations of serum syndecan-1 and heparan sulfate before and after surgery.
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)
盲法说明
triple blinded (Participant, Care Provider, investigator)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with between 30 and 80 years scheduled for posterior lumbar spinal fusion surgery.
排除标准
- •emergency surgery
- •patients unable to make their own decisions, illiterate, foreigners
- •Allergy / hypersensitivity to Tranexamic acid
- •Current or past history or thrombosis / thromboembolism
- •patients who are taking oral contraceptives
- •Patients with renal insufficiency (eGFR 60 ml / min / 1.73 m 2 or less)
- •Patients receiving anticoagulants
- •pregnant and lactating women
研究组 & 干预措施
Glutamine
Intravenous glutamine infusion perioperatively for 18 hours (8 hours before surgery and 10 hours after induction of anesthesia)
干预措施: Tranexamic acid (Drug)
Placebo
placebo
干预措施: 0.9% NaCl (normal saline) (Drug)
结局指标
主要结局
blood concentration of syndecan-1, heparan sulfate at the end of the surgery
时间窗: within 5 minutes after the end of surgery (when thd surgical drape is removed)
blood concentration of syndecan-1, heparan sulfate at the end of the surgery
base blood concentration of syndecan-1, heparan sulfate
时间窗: within 1 hour before surgery(base concentration)
preoperative baseline serum levels of syndecan-1 and heparan sulfate
blood concentration of syndecan-1, heparan sulfate at 2 hours after surgery
时间窗: 2 hours after the end of surgery
blood concentration of syndecan-1, heparan sulfate at 2 hours after surgery
次要结局
未报告次要终点