Multicenter, Randomized Placebo-controlled Clinical Trial to Evaluate the Effect of Perioperative Use of Tranexamic Acid on Transfusion Requirements and Surgical Bleeding in Major Spine Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 4
- 主要终点
- The primary outcome measure is the number of transfused units required during the intraoperative and postoperative period
研究概览
简要总结
Current evidence regarding the efficacy and safety of perioperative administration of tranexamic acid for antifibrinolysis does not suffice to support its use in major spinal surgery.
OBJECTIVES: To evaluate the effectiveness of tranexamic acid for decreasing transfusion requirements and bleeding in this patient population. To evaluate the safety of this antifibrinolytic agent in the intraoperative and mid-term postoperative period.
METHODS: Multicenter, randomized, double-blind, placebo-controlled clinical trial with parallel groups. The main outcome measure is intraoperative and postoperative transfusion requirements; blood loss and safety will also be evaluated. Previous results in other types of surgery suggest that tranexamic acid reduces transfusion requirements and blood loss. Hence, the hypothesis of this study is that tranexamic acid will significantly reduce blood loss in comparison to a placebo in major spine surgery.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥18 years old of both sexes
- •scheduled for complex spine surgery
- •ASA I-III
- •weighing more than 30 kg
- •body mass index <30 kg/m2
- •operated on in the participating hospitals
- •major spinal surgery
- •signed an informed consent form to be included in the study
排除标准
- •a history of allergy or hypersensitivity to the agent used
- •receiving medication that can interfere with coagulation (acetylsalicylic acid, oral anticoagulants, or antiplatelet agents)
- •a history of frequent bleeding
- •plasma creatinine values >1.5 mg/dL in the baseline analysis
- •platelet count less than 150,000/mm3 in the follow-up analysis
- •abnormal prothrombin time (INR >1.5) or partial thromboplastin time (INR >1.5)
- •a history of a thromboembolic episode before surgery
- •family history of thromboembolism
- •lack of consent to participate in the study
- •infectious disease, tumor or trauma of the spine as the reason for surgery
- •scheduled for surgery with an anterior and posterior surgical approach, whether sequential or on the same day
研究组 & 干预措施
tranexamic acid
tranexamic acid will be administered as a bolus (10-mg/kg dose ) or as a fast, 20-minute intravenous infusion before performing the incision at the start of surgery, followed by perfusion of 2 mg/kg/hour up to the time the surgical wound is closed at completion of surgery
干预措施: Tranexamic Acid (Drug)
placebo
The placebo will be administered according to the same regimen and infusion time as the medication in the study arm (bolus or 20-minute fast infusion before the incision at the beginning of surgery followed by perfusion of 2 mg/kg/hour until closure of the surgical wound at completion of surgery)
干预措施: fisiologic serum (Drug)
结局指标
主要结局
The primary outcome measure is the number of transfused units required during the intraoperative and postoperative period
时间窗: 7 days postoperative period
次要结局
- Total blood loss: intraoperative and postoperative values(48 hours postoperative)
- Adverse events in the perioperative period, immediate postoperative period, and at mid-term(up to 6 weeks after the procedure)