Division of Pediatric Critical Care, Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI, USA.
Division of Congenital Heart Surgery and Herma Heart Institute, Department of Surgery, Medical College of Wisconsin, Milwaukee, WI, USA.
World J Pediatr Congenit Heart Surg. 2023 May;14(3):282-288. doi: 10.1177/21501351231162911. Epub 2023 Mar 15.
This study aims to compare the efficacy and safety of activated recombinant factor VII (rFVIIa) and prothrombin complex concentrate (PCC) in the treatment of bleeding complications following surgery requiring cardiopulmonary bypass (CPB) in children.
DESIGN/METHODS: This is a retrospective chart review of a single institution comprising patients aged 0 to 18 years old with congenital heart disease. Patients must have received either PCC or rFVIIa after coming off CPB. Our primary efficacy endpoint is time in the operating room from off-CPB to pediatric intensive care unit admission. Our primary safety endpoint is thrombosis through 30 days.
Our primary efficacy outcome was significantly shorter in the PCC group compared with the rFVIIa group ( < .0001). Similarly, secondary efficacy outcomes of packed red blood cell administration, chest tube output, and transfusion exposures all significantly favored PCC administration. However, CPB time was significantly longer, and body temperatures were significantly lower, in the rFVIIa group. Safety outcomes, including our primary safety outcome of thrombosis through 30 days, were similar between the two groups.
This study questions whether PCC could be favored over rFVIIa for hemostasis in children with congenital heart disease following CPB surgery. In addition, this study has found no difference when comparing PCC and rFVIIa in terms of safety outcomes, particularly thrombosis events. There are several limitations to this study due to the retrospective nature of the design and the differences between the two study groups. Despite the limitations, this study suggests that relatively early administration of PCC could be favored over delayed administration of rFVIIa to control recalcitrant post-CPB bleeding in the operating room.
本研究旨在比较激活重组凝血因子 VII（rFVIIa）和凝血酶原复合物浓缩物（PCC）在治疗儿童体外循环（CPB）后手术出血并发症的疗效和安全性。
设计/方法：这是一项对一家单机构的回顾性图表审查，包括年龄在 0 至 18 岁的先天性心脏病患者。患者必须在离开 CPB 后接受 PCC 或 rFVIIa。我们的主要疗效终点是从离开 CPB 到小儿重症监护病房入院的手术室内时间。我们的主要安全性终点是 30 天内的血栓形成。
我们的主要疗效结果在 PCC 组明显短于 rFVIIa 组（ < 0.0001）。同样，PCC 给药明显有利于二次疗效结果，如红细胞悬液的输注、胸腔引流管输出和输血暴露。然而，rFVIIa 组的 CPB 时间明显延长，体温明显降低。安全性结果，包括我们的 30 天内血栓形成的主要安全性结果，两组相似。
本研究对 PCC 是否可以优于 rFVIIa 用于 CPB 手术后患有先天性心脏病的儿童的止血提出了质疑。此外，本研究在安全性结果方面，特别是在血栓形成事件方面，发现 PCC 和 rFVIIa 之间没有差异。由于设计的回顾性和两组之间的差异，本研究存在一些局限性。尽管存在这些局限性，但本研究表明，与延迟给予 rFVIIa 相比，相对较早给予 PCC 可能有利于控制手术室中 CPB 后顽固的出血。
