Blood Loss and Transfusion Requirement in Infants Treated With Tranexamic Acid Undergoing Craniosynostosis Reconstruction: A Randomized Placebo-Controlled Double Blind Study of Low and High Dose Therapy
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Blood Loss
研究概览
简要总结
The primary objective of this study is to investigate whether tranexamic acid (TXA) reduces perioperative blood loss and transfusion requirement in infants undergoing craniosynostosis surgery.
详细描述
Blood loss during pediatric craniosynostosis surgery can be significant and this may be exacerbated by a dilutional coagulopathy. Multimodal blood conservation strategies may limit allogeneic transfusions, although RCTs are few and limited. It is essential to investigate these techniques to determine their potential to reduce allogeneic blood transfusions and their associated cost and morbidity.
Tranexamic acid (TXA) is a synthetic antifibrinolytic drug that competitively inhibits the lysine binding sites of plasminogen, plasmin, and tissue plasminogen activator. The result is inhibition of fibrinolysis and clot degradation.
Recent studies in adults undergoing cardiac surgery demonstrated that people with different genotypes for the plasminogen activator inhibitor-1 (PAI-1) gene may have varying degrees of bleeding. PAI-1 inhibits the transformation of plasminogen to plasmin thereby decreasing plasmin-induced fibrinolysis. Thus, PAI-1 promotes clot stability and the PAI-1 polymorphism will affect the degree of bleeding and response to TXA during craniosynostosis 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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Months 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants aged 2 months to 2 years undergoing anterior cranial vault reconstruction
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
- •Acquired colour vision defects as one of the first signs of long term TXA toxicity is colour vision disturbance.
研究组 & 干预措施
Low Dose
TXA 10mg/kg bolus before incision and 5 mg/kg infusion until skin closure
干预措施: Tranexamic Acid (Drug)
High Dose
TXA 100 mg/kg bolus before incision and 10 mg/kg infusion until skin closure
干预措施: Tranexamic Acid (Drug)
Placebo
Normal saline 10 ml before skin incision and infusion according to weight until skin closure
干预措施: Saline Placebo (Drug)
结局指标
主要结局
Blood Loss
时间窗: Prior and Post Surgery
Blood loss will be carefully measured in sponges, suction cannisters, cell saver systems, and in the plastic pockets of surgical drapes.
次要结局
- Plasminogen Activator Inhibitor-1 (PAI-1) Polymorphism - Samples(Sample will be drawn immediately after induction and prior to administration of study drug)
- Thromboelastography (TEG)Sample(Baseline, immediately after bolus dose of TXA is infused)
研究者
Tara Der
Staff Anesthesiologist
The Hospital for Sick Children