Blood Loss and Transfusion Requirement in Pediatric Patients With Non-Idiopathic Scoliosis Treated With Tranexamic Acid Undergoing Posterior Spinal Instrumentation and Fusion.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Perioperative blood loss and transfusion requirement
研究概览
简要总结
Investigation of tranexamic acid (TXA) for reducing perioperative blood loss and transfusion requirement in pediatric patients with secondary scoliosis undergoing posterior spinal fusion.
详细描述
To investigate whether tranexamic acid (TXA) reduces perioperative blood loss and transfusion requirement in pediatric patients with secondary scoliosis undergoing posterior spinal fusion.In addition determination of the optimal TXA dosing for perioperative reduction of blood loss and transfusion requirement as well as to evaluate use of thromboelastography (TEG) as a measure of coagulation and fibrinolysis in pediatric patients with secondary scoliosis undergoing posterior spinal fusion (this may help guide blood product therapy).
The investigation will determine the effects of TXA on the TEG profile and whether plasminogen activator inhibitor-1 (PAI-1) level affects bleeding and transfusion requirement during scoliosis surgery. Finally to investigate whether PAI-1 level affects bleeding in response to TXA during scoliosis surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with secondary scoliosis undergoing posterior spinal fusion
排除标准
- •Known bleeding disorder as this may increase the risk of bleeding
- •Current antifibrinolytic therapy as these patients may bleed less
- •Patient or family history of thromboembolic disease as there may be potential risk of thrombosis
- •Use of NSAIDS within 5 days of surgery as this may increase the risk of bleeding
- •Known allergy to TXA
- •History of renal insufficiency as TXA is renally excreted
- •Colour vision disturbance
研究组 & 干预措施
. Tranexamic acid low dose 10 mg/kg
干预措施: Tranexamic acid 10mg/kg/hr (Drug)
Tranexamic acid 100mg/kg
干预措施: Tranexamic acid 100 mg/kg/h infusion (Drug)
Saline Placebo
干预措施: Saline solution (Drug)
结局指标
主要结局
Perioperative blood loss and transfusion requirement
时间窗: 8 hours
次要结局
- Thromboelastography (TEG): TEG monitors coagulation of blood samples in vitro to produce a complete picture of clot formation, strength and dissolution (i.e. fibrinolysis).(After Induction- Prior to Drug Administration, Immediately after Bolus Dose)
- Plasminogen Activator Inhibitor-1(Baseline -Immediately after induction and prior to administration of study drug)
研究者
Tara Der
Staff Anaesthesiologist
The Hospital for Sick Children