The Use of Tranexamic Acid to Reduce Perioperative Blood Loss During High Risk Spine Fusion Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Total Red Blood Cells Transfused in the Intraoperative Period
研究概览
简要总结
The purpose of this study is to determine if tranexamic acid reduces perioperative blood loss and red blood cell transfusion during high risk spine surgery.
详细描述
There are conflicting studies in the literature reporting different efficacy outcomes for the use of antifibrinolytics in spine fusion surgery. Several studies support the successful use of tranexamic acid for major orthopedic procedures, but the patient populations studied for spine surgery thus far have been small and highly variable, with less than clinically significant results. If TXA if efficacious in reducing not only perioperative blood loss, but RBC transfusion without an increase in thromboembolic events, then its use may be justified for patients at risk for major blood transfusion.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age>17 years
- •undergoing posterior spine fusion surgery for kyphoscoliosis with a >80% chance of major transfusion
排除标准
- •age < 18 years
- •non-English speaking
- •pregnancy
- •emergency procedures
- •surgery for tumor, trauma or infection
- •severe coronary artery disease
- •history of venous thromboembolism
- •history of cerebral vascular accident
- •history of renal insufficiency
- •allergy to tranexamic acid
研究组 & 干预措施
Tranexamic Acid
Tranexamic acid 10mg/kg loading dose given pre-incision and 1mg/kg/hr infusion throughout intraoperative period
干预措施: Tranexamic Acid (Drug)
Placebo
Normal saline placebo loading dose 0.5ml/kg and infusion at 0.5ml/kg/hr throughout operative course
干预措施: Tranexamic Acid (Drug)
结局指标
主要结局
Total Red Blood Cells Transfused in the Intraoperative Period
时间窗: Intraoperative period (approximately 12 hours)
Total red blood cells transfused in the intraoperative period in (mL). Total RBC equal packed red blood cells and cell saver infusion.
次要结局
- Additional Blood Products Transfused(24 hours after skin incision)
- Post Operative Major Morbidity(Time of surgery to date of discharge from hospital (average 7 days))
研究者
Louanne Carabini
Assistant Professor of Anesthesiology & Neurological Surgery
Northwestern University