Department of Anesthesiology, Critical Care and Pain Medicine, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.
Department of Anesthesiology, Critical Care and Pain Medicine, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.
Br J Anaesth. 2020 Sep;125(3):336-345. doi: 10.1016/j.bja.2020.05.054. Epub 2020 Jun 30.
Tranexamic acid (TXA) reduces blood loss and transfusion in paediatric craniosynostosis surgery. The hypothesis is that low-dose TXA, determined by pharmacokinetic modelling, is non-inferior to high-dose TXA in decreasing blood loss and transfusion in children.
Children undergoing craniosynostosis surgery were enrolled in a two-centre, prospective, double-blind, randomised, non-inferiority controlled trial to receive high TXA (50 mg kg followed by 5 mg kg h) or low TXA (10 mg kg followed by 5 mg kg h). Primary outcome was blood loss. Low dose was determined to be non-inferior to high dose if the 95% confidence interval (CI) for the mean difference in blood loss was above the non-inferiority margin of -20 ml kg. Secondary outcomes were transfusion, TXA plasma concentrations, and biological markers of fibrinolysis and inflammation.
Sixty-eight children were included. Values were non-inferior regarding blood loss (39.4 [4.4] vs 40.3 [6.2] ml kg [difference=0.9; 95% CI: -14.2, 15.9]) and blood transfusion (21.3 [1.6] vs 23.6 [1.5] ml kg [difference=2.3; 95% CI: -2.1, 6.7]) between high-dose (n=32) and low-dose (n=34) groups, respectively. The TXA plasma concentrations during surgery averaged 50.2 (8.0) and 29.6 (7.6) μg ml. There was no difference in fibrinolytic and inflammatory biological marker concentrations. No adverse events were observed.
Tranexamic acid 10 mg kg followed by 5 mg kg h is not less effective than a higher dose of 50 mg kg and 5 mg kg h in reducing blood loss and transfusion in paediatric craniosynostosis surgery.
NCT02188576.
氨甲环酸（TXA）可减少小儿颅缝早闭手术中的失血量和输血。假设通过药代动力学模型确定的低剂量 TXA 在减少儿童失血和输血方面不劣于高剂量 TXA。
在一项两中心、前瞻性、双盲、随机、非劣效性对照试验中，接受颅缝早闭手术的儿童被纳入研究，接受高 TXA（50mg/kg 后 5mg/kg/h）或低 TXA（10mg/kg 后 5mg/kg/h）治疗。主要结局为失血量。如果失血量的平均差值的 95%置信区间（CI）高于非劣效性边界-20ml/kg，则认为低剂量不劣于高剂量。次要结局为输血、TXA 血浆浓度以及纤溶和炎症的生物标志物。
共纳入 68 例患儿。两组间失血量（39.4[4.4]vs40.3[6.2]ml/kg[差值=0.9；95%CI：-14.2，15.9]）和输血（21.3[1.6]vs23.6[1.5]ml/kg[差值=2.3；95%CI：-2.1，6.7]）值均无统计学差异。术中 TXA 血浆浓度平均为 50.2（8.0）和 29.6（7.6）μg/ml。纤溶和炎症生物标志物浓度无差异。未观察到不良事件。
氨甲环酸 10mg/kg 后 5mg/kg/h 的效果不劣于 50mg/kg 和 5mg/kg/h 的较高剂量，可减少小儿颅缝早闭手术中的失血量和输血。
NCT02188576。
