Haas T, Spielmann N, Restin T, Seifert B, Henze G, Obwegeser J, Min K, Jeszenszky D, Weiss M, Schmugge M
Department of Anaesthesia, University Children's Hospital Zurich, Steinwiesstrasse 75, 8032 Zurich, Switzerland
Department of Anaesthesia, University Children's Hospital Zurich, Steinwiesstrasse 75, 8032 Zurich, Switzerland.
Br J Anaesth. 2015 Aug;115(2):234-43. doi: 10.1093/bja/aev136. Epub 2015 May 15.
Hypofibrinogenaemia is one of the main reasons for development of perioperative coagulopathy during major paediatric surgery. The aim of this study was to assess whether prophylactic maintenance of higher fibrinogen concentrations through administration of fibrinogen concentrate would decrease the volume of transfused red blood cell (RBCs).
In this prospective, randomised, clinical trial, patients aged 6 months to 17 yr undergoing craniosynostosis and scoliosis surgery received fibrinogen concentrate (30 mg kg(-1)) at two predefined intraoperative fibrinogen concentrations [ROTEM(®) FIBTEM maximum clot firmness (MCF) of <8 mm (conventional) or <13 mm (early substitution)]. Total volume of transfused RBCs was recorded over 24 h after start of surgery.
Thirty children who underwent craniosynostosis surgery and 19 children who underwent scoliosis surgery were treated per protocol. During craniosynostosis surgery, children in the early substitution group received significantly less RBCs (median, 28 ml kg(-1); IQR, 21 to 50 ml kg(-1)) compared with the conventional fibrinogen trigger of <8 mm (median, 56 ml kg(-1); IQR, 28 to 62 ml kg(-1)) (P=0.03). Calculated blood loss as per cent of estimated total blood volume decreased from a median of 160% (IQR, 110-190%) to a median of 90% (IQR, 78-110%) (P=0.017). No significant changes were observed in the scoliosis surgery population. No bleeding events requiring surgical intervention, postoperative transfusions of RBCs, or treatment-related adverse events were observed.
Intraoperative administration of fibrinogen concentrate using a FIBTEM MCF trigger level of <13 mm can be successfully used to significantly decrease bleeding, and transfusion requirements in the setting of craniosynostosis surgery, but not scoliosis.
ClinicalTrials.gov NCT01487837.
纤维蛋白原血症是小儿重大手术围手术期凝血病发生的主要原因之一。本研究旨在评估通过输注纤维蛋白原浓缩物预防性维持较高纤维蛋白原浓度是否会减少红细胞（RBC）的输注量。
在这项前瞻性、随机临床试验中，年龄在6个月至17岁接受颅缝早闭和脊柱侧弯手术的患者，在两个预先定义的术中纤维蛋白原浓度[ROTEM® FIBTEM最大血凝块硬度（MCF）<8mm（传统组）或<13mm（早期替代组）]时接受纤维蛋白原浓缩物（30mg/kg）。记录手术开始后24小时内输注RBC的总量。
30例接受颅缝早闭手术的儿童和19例接受脊柱侧弯手术的儿童按方案接受治疗。在颅缝早闭手术期间，早期替代组儿童输注的RBC明显少于传统组纤维蛋白原触发水平<8mm的儿童（中位数，28ml/kg；四分位间距，21至50ml/kg）（中位数，56ml/kg；四分位间距，28至62ml/kg）（P=0.03）。计算的失血量占估计总血容量的百分比从中位数160%（四分位间距，110 - 190%）降至中位数90%（四分位间距，78 - 110%）（P=0.017）。在脊柱侧弯手术人群中未观察到显著变化。未观察到需要手术干预、术后输注RBC或治疗相关不良事件的出血事件。
术中使用FIBTEM MCF触发水平<13mm输注纤维蛋白原浓缩物可成功显著减少颅缝早闭手术中的出血和输血需求，但对脊柱侧弯手术无效。
ClinicalTrials.gov NCT01487837
