The Efficacy of Intravenous Tranexamic Acid in Decreasing Blood Loss in Pediatric Idiopathic Scoliosis Surgery?
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Perioperative Blood Loss
研究概览
简要总结
Adolescent idiopathic scoliosis surgery is an extensive procedure associated with significant blood loss frequently requiring the transfusion of blood. Tranexamic acid (TXA) is a synthetic antifibrinolytic (prevents breakdown of the blood clot) that has been used to extensively reduce transfusion in pediatric major surgery, including cardiac, craniofacial and orthopedic surgery. In this prospective randomized double-blinded study, the investigators wish to evaluate the hypothesis that TXA is more effective than standard of care at decreasing blood loss and blood transfusion perioperatively in children and adolescents undergoing idiopathic scoliosis surgery.
详细描述
This prospective randomized double-blinded study will enroll 120 children and adolescents ages undergoing scoliosis repair with the diagnosis of idiopathic scoliosis. The primary aim is to determine if intravenous infusion of TXA is more effective than standard care (no TXA) at decreasing blood loss and blood transfusion perioperatively in children and adolescents presenting for scoliosis surgery.
Aims:
- Investigate and compare the efficacy of TXA (as measured by intraoperative blood loss and blood transfusion) intravenously administered during surgery vs placebo in patients with idiopathic scoliosis coming for surgery.
- Determine the PK profile of TXA in children and adolescents undergoing scoliosis surgery.
- Investigate the contribution of these different factors (plasma concentration of TXA, age related differences in PK/PD and renal function, and polymorphism of the Plasminogen activator inhibitor-1 (PAI-1) gene and PAI-1 levels with TXA efficacy in pediatric patients undergoing and scoliosis surgery.
- Determine the safety profile of intravenous TXA in children and adolescents presenting for scoliosis surgery.
Following a standardized general anesthetic protocol, patients coming with idiopathic scoliosis will be randomized to either:
- placebo i.e. saline 0.9% (intravenous injection)
- intravenous TXA given as a loading dose over 15 minutes of 50 mg/kg bolus ( 30- 60 minutes prior to surgical incision) and 10 mg/kg/hr infusion for the duration of the 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)
入排标准
- 年龄范围
- 10 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children and adolescents (age 10-21 yr) for elective Idiopathic scoliosis corrective surgery; posterior repair.
排除标准
- •Preexisting coagulopathy, (INR>1.4, PTT>1.4xN, PT>1.4xN, platelet count<150,000/mm3), severe hematological disorders, hepatic failure, or renal failure. Ingestion of acetylsalicylate within 14 days or NSAIDs within 2 days of the scheduled surgery date; history of prior blood transfusion. Pre-donation of autologous blood. Patients having anterior-posterior repair.
研究组 & 干预措施
Placebo
Placebo ( 0.9% Normal saline) intravenously given as a 0.5 ml/kg loading dose over 15 minutes followed by a 0.1 ml/kg/hr continuous infusion throughout the surgery.
干预措施: Placebo (Drug)
Tranexamic acid
Tranexamic acid 100 mg/ml; 50 mg/kg loading dose = 0.5 ml/kg LD given over 15 minutes and 10 mg/kg/hr = 0.1 ml/kg/hr infusion for the duration of the surgery.
干预措施: Tranexamic Acid (Drug)
结局指标
主要结局
Perioperative Blood Loss
时间窗: perioperarively - during entire hospital admission
Perioperative blood loss (during operation and for entire hospital admission)
次要结局
未报告次要终点
研究者
Susan Goobie
Assistant in Anesthesia
Boston Children's Hospital