Labatt Family Heart Centre, Department of Pediatrics, University of Toronto, The Hospital for Sick Children, Toronto, Ontario, Canada.
J Am Coll Cardiol. 2010 Nov 23;56(22):1794-802. doi: 10.1016/j.jacc.2010.06.046.
We sought to determine whether infants (younger than 1 year old) had similar clinical benefits with individualized anticoagulation management as older children and adult undergoing cardiopulmonary bypass (CPB).
Individualized heparin and protamine management in older children and adults undergoing CPB has been associated with improved clinical outcomes.
Ninety infants younger than 1 year of age undergoing CPB were enrolled in a randomized, controlled trial comparing weight-based anticoagulation management using activated clotting time (ACT) to individualized management with Hemostasis Management System Plus. Manufacturer's guidelines were followed for the first 33 patients. A modified protocol was used for the last 57 patients with adjustments for coagulation system immaturity and hemodilution on CPB.
The hemostasis management system (HMS) device consistently underestimated plasma anti-Xa levels, leading to an overestimated required heparin dose. After a blinded interim analysis revealed poor outcomes in the experimental HMS group using manufacturer guidelines, the safety committee suspended the study pending protocol modifications. The use of the HMS device following the modified protocol resulted in more stable anti-Xa levels during CPB with improved post-operative outcomes including reduced need for transfusions (71 ml/kg vs. 80 ml/kg; p = 0.003), ventilation time (33 h vs. 49 h; p = 0.04), intensive care (88 h vs. 99 h; p = 0.003), and hospital length of stay (192 h vs. 216 h; p < 0.001), compared with the weight-based protocol.
This study supports the use of the HMS device, with a modified protocol for infants younger than 1 year of age, for anticoagulation management during CPB. Clinical guidelines for the use of the HMS device should be modified for infants younger than 1 year of age.
我们旨在确定婴儿（1 岁以下）接受心肺转流术（CPB）时，采用个体化抗凝管理方案是否与较大儿童和成人一样具有相似的临床获益。
CPB 中对较大儿童和成人采用个体化肝素和鱼精蛋白管理与改善临床结局相关。
90 名 1 岁以下婴儿接受 CPB 治疗，被纳入一项比较采用激活凝血时间（ACT）的体重抗凝管理与采用止血管理系统（HMS）进行个体化管理的随机对照试验。前 33 名患者遵循制造商指南。对最后 57 名患者采用改良方案，根据 CPB 时凝血系统不成熟和血液稀释情况进行调整。
HMS 装置持续低估血浆抗 Xa 水平，导致肝素剂量估计过高。在盲法中期分析显示采用制造商指南的实验组 HMS 结果较差后，安全委员会暂停该研究，等待方案修改。在采用改良方案后，HMS 装置的使用导致 CPB 期间抗 Xa 水平更稳定，术后结局改善，包括减少输血需求（71 ml/kg 比 80 ml/kg；p = 0.003）、通气时间（33 h 比 49 h；p = 0.04）、重症监护时间（88 h 比 99 h；p = 0.003）和住院时间（192 h 比 216 h；p < 0.001）。
本研究支持在婴儿中使用 HMS 装置，并采用改良方案进行 CPB 时的抗凝管理。应修改婴儿使用 HMS 装置的临床指南。
