Franziskus Hospital, Bielefeld, Germany.
Duke University School of Medicine, Durham, North Carolina, USA.
Blood Coagul Fibrinolysis. 2021 Sep 1;32(6):359-365. doi: 10.1097/MBC.0000000000001046.
Haemorrhage during and following surgery results in increased morbidity and mortality. Low plasma fibrinogen levels have been associated with increased blood loss and transfusion requirements. Fibrinogen supplementation has been shown to reduce bleeding in coagulopathic patients. This post hoc study evaluated fibrinogen repletion and pharmacokinetic data from the REPLACE study. One hundred and fifty-two adult patients undergoing elective aortic surgery requiring cardiopulmonary bypass (CPB) with defined bleeding of 60-250 g at first 5 min bleeding mass were included in the phase III trial. Patients were randomized to receive either fibrinogen concentrate (FCH) or placebo following CPB removal. Plasma fibrinogen levels and viscoelastic testing parameters (ROTEM-based FIBTEM and EXTEM assays) were measured before, during, and after study treatment administration. A mean dose of 6.3 g FCH was administered in the FCH group, with a median infusion duration of 2 min. Immediately following completion of FCH administration, a rapid increase in plasma fibrinogen levels to near baseline (median change from baseline -0.10 g/l) was seen in the FCH group but not in the placebo group (median change from baseline -1.29 g/l). FCH administration also caused an immediate increase in FIBTEM maximum clot firmness (MCF) to 23 mm and improvements in EXTEM coagulation time and clot formation time by the end of infusion. There was a strong correlation between the plasma fibrinogen level and FIBTEM MCF. Treatment with high doses of FCH with a rapid infusion time resulted in immediate recovery to baseline levels of plasma fibrinogen and viscoelastic testing parameters.
术中及术后出血可导致发病率和死亡率增加。低血浆纤维蛋白原水平与出血量增加和输血需求增加有关。纤维蛋白原补充已被证明可减少凝血功能障碍患者的出血。本事后研究评估了 REPLACE 研究中的纤维蛋白原补充和药代动力学数据。152 名接受择期主动脉手术的成年患者纳入了这项 III 期试验,这些患者需要体外循环 (CPB) ,CPB 去除后随机接受纤维蛋白原浓缩物 (FCH) 或安慰剂治疗。在研究治疗给药前、期间和之后测量了血浆纤维蛋白原水平和粘弹性检测参数(基于 ROTEM 的 FIBTEM 和 EXTEM 测定)。FCH 组给予平均剂量 6.3g FCH,中位输注时间为 2 分钟。在 FCH 给药完成后,立即观察到 FCH 组的血浆纤维蛋白原水平迅速增加至接近基线(与基线相比的中位数变化-0.10g/l),而安慰剂组没有观察到这种变化(与基线相比的中位数变化-1.29g/l)。FCH 给药还导致 FIBTEM 最大凝块硬度 (MCF) 立即增加至 23mm,并在输注结束时改善 EXTEM 凝血时间和凝块形成时间。血浆纤维蛋白原水平与 FIBTEM MCF 之间存在很强的相关性。用快速输注时间给予高剂量 FCH 治疗可立即恢复至基线水平的血浆纤维蛋白原和粘弹性检测参数。