Activated recombinant factor VII after cardiopulmonary bypass reduces allogeneic transfusion in complex non-coronary cardiac surgery: randomized double-blind placebo-controlled pilot study
Activated recombinant factor VII after cardiopulmonary bypass reduces allogeneic transfusion in complex non-coronary cardiac surgery: randomized double-blind placebo-controlled pilot study
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DOI：
10.1093/bja/aei244
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发表时间：
2005-11-01
影响因子：
9.8
通讯作者：
Gill, RS
中科院分区：
文献类型：
--
作者：
Diprose, P;Herbertson, MJ;Gill, RS
背景接受同种异体输血可能是心脏手术患者死亡率的独立预测因素。此外，这些患者使用了英国所有捐献血液的15%。在我们的单位，80%的患者接受复杂的非冠状动脉心脏手术，需要心肺转流（CPB）接受同种异体输血。活化的重组FVII（rFVIIa）可有效减少这种输血需求。20例接受复杂心脏手术的患者在CPB和肝素逆转后随机接受rFVIIa或安慰剂。rFVIIa组2例患者接受了13个单位的同种异体红细胞和凝血产品，而安慰剂组8例患者接受了105个单位的同种异体红细胞和凝血产品（任何输血的相对风险0.26;置信区间0.07-0.9; P=0.037）。两组在不良事件方面无差异。尽管存在重大局限性（研究效力不足且易于发生I型错误），但我们已证明rFVIIa可显著降低复杂非冠状动脉心脏手术中同种异体输血的需求，且不会引起不良事件。
Background. Receiving an allogeneic transfusion may be an independent predictor of mortality for patients undergoing cardiac surgery. Furthermore, these patients utilize 15% of all donated blood in the UK. In our unit, 80% of patients undergoing complex non-coronary cardiac surgery requiring cardiopulmonary bypass (CPB) receive an allogeneic transfusion. Activated recombinant FVII (rFVIIa) may be effective in reducing this need for transfusion.Methods. Twenty patients undergoing complex cardiac surgery were randomized to receive rFVIIa or placebo after CPB and reversal of heparin.Results. Two patients in the rFVIIa group received 13 units of allogeneic red cells and coagulation products compared with eight patients receiving 105 units of allogeneic red cells and coagulation products in the placebo group (relative risk of any transfusion 0.26; confidence interval 0.07-0.9; P=0.037). The groups did not differ for adverse events.Conclusion. Despite major limitations (underpowered study and prone to type I error), we have shown that rFVIIa significantly reduces the need for allogeneic transfusion in complex non-coronary cardiac surgery without causing adverse events.