Department of Pharmacy, 12297NYU Langone Health, New York, NY, USA.
J Intensive Care Med. 2022 Feb;37(2):231-239. doi: 10.1177/0885066620984443. Epub 2021 Jan 5.
Bleeding following cardiac surgery that warrants transfusion of blood products is associated with significant complications, including increased mortality at 1 year following surgery. Factor concentrates, such as prothrombin complex concentrate (PCC), or recombinant activated factor VII (rFVIIa) have been used off-label for bleeding in cardiac surgery that is refractory to conventional therapy. The objective of this retrospective study is to assess the hemostatic effectiveness of 4-factor PCC or rFVIIa for bleeding after a broad range of cardiac surgeries. Patients were included if they were at least 18 years of age and had undergone cardiac surgery with bleeding requiring intervention with 4-factor PCC or rFVIIa. There were no differences observed in the number of packed red blood cells (4-factor PCC: 2 units vs. rFVIIa: 2 units), fresh frozen plasma (0 units vs. 1 unit) or platelet (2 units vs. 2 units) transfusions following the administration of 4-factor PCC or rFVIIa. The patients in the rFVIIa group, required more cryoprecipitate than those in the 4-factor PCC group (4-factor PCC: 2 units (range 0-6) vs. rFVIIa: 2 units (range 0-8), p = 0.03). There were no differences in secondary outcomes of chest tube output at 2, 6, 12 and 24 hours, nor was there a difference in reexploration rates or the median length of stay in the intensive care unit. Thromboembolic complications at 30 days were similar between the two groups (4-factor PCC: 13% vs. rFVIIa 26%, p = 0.08). The total median dose requirement for 4-factor PCC was 1000 units (15 units/kg) and 2 mg (20 mcg/kg) for rFVIIa. The results demonstrate feasibility of utilizing the minimum amount of drug in order to achieve a desired effect. Both 4-factor PCC and rFVIIa appear to be safe and effective options for the management of bleeding associated with cardiac surgery.
心脏手术后需要输血的出血与严重并发症相关，包括手术后 1 年死亡率增加。因子浓缩物，如凝血酶原复合物浓缩物（PCC）或重组活化因子 VII（rFVIIa）已被用于心脏手术中常规治疗无效的出血。本回顾性研究的目的是评估 4 因子 PCC 或 rFVIIa 治疗多种心脏手术后出血的止血效果。如果患者年龄至少 18 岁，并且接受了心脏手术并有出血需要用 4 因子 PCC 或 rFVIIa 干预，则纳入患者。在给予 4 因子 PCC 或 rFVIIa 后，观察到输注的红细胞（4 因子 PCC：2 单位 vs. rFVIIa：2 单位）、新鲜冷冻血浆（0 单位 vs. 1 单位）或血小板（2 单位 vs. 2 单位）数量无差异。rFVIIa 组的患者需要比 4 因子 PCC 组更多的冷沉淀（4 因子 PCC：2 单位（范围 0-6）vs. rFVIIa：2 单位（范围 0-8），p = 0.03）。2、6、12 和 24 小时的胸腔引流管输出量、再次探查率或 ICU 住院时间中位数无差异。两组 30 天的血栓栓塞并发症相似（4 因子 PCC：13% vs. rFVIIa 26%，p = 0.08）。4 因子 PCC 的总中位剂量需求为 1000 单位（15 单位/千克），rFVIIa 为 2 毫克（20 微克/千克）。结果表明，为了达到预期效果，使用最小剂量的药物是可行的。4 因子 PCC 和 rFVIIa 似乎都是心脏手术后出血管理的安全有效选择。
