预防性输注纤维蛋白原可减少冠状动脉搭桥手术后的出血。一项前瞻性随机试点研究。

Prophylactic fibrinogen infusion reduces bleeding after coronary artery bypass surgery. A prospective randomised pilot study.

作者信息

Karlsson Martin, Ternström Lisa, Hyllner Monica, Baghaei Fariba, Flinck Agneta, Skrtic Stanko, Jeppsson Anders

机构信息

Department of Cardiothoracic Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden.

出版信息

Thromb Haemost. 2009 Jul;102(1):137-44. doi: 10.1160/TH08-09-0587.

Abstract

It has been suggested that preoperative fibrinogen plasma concentration is independently associated to postoperative blood loss after cardiac surgery. Theoretically, prophylactic infusion of fibrinogen concentrate may thus reduce postoperative bleeding, but this has not previously been investigated. Twenty elective coronary artery bypass graft (CABG) patients with preoperative plasma fibrinogen levels <3.8 g/l were included in a prospective randomised pilot study. Patients were randomised to receive an infusion of 2 g fibrinogen concentrate (FIB group) or no infusion before surgery (control group). Primary endpoint was safety with clinical adverse events and graft occlusion assessed by multi-slice computed tomography. Predefined secondary endpoints were postoperative blood loss, blood transfusions, haemoglobin levels 24 hours (h) after surgery, and global haemostasis assessed with thromboelastometry, 2 and 24 hours after surgery. Infusion of 2 g fibrinogen concentrate increased plasma levels of fibrinogen by 0.6 +/- 0.2 g/l. There were no clinically detectable adverse events of fibrinogen infusion. Computed tomography revealed one subclinical vein graft occlusion in the FIB group. Fibrinogen concentrate infusion reduced postoperative blood loss by 32% (565 +/- 150 vs. 830 +/- 268 ml/12 h, p=0.010). Haemoglobin concentration was significantly higher 24 h after surgery in the FIB group (110 +/- 12 vs. 98 +/- 8 g/l, p=0.018). Prophylactic fibrinogen concentrate infusion did not influence global postoperative haemostasis as assessed by thromboelastometry. In conclusion, in this pilot study preoperative fibrinogen concentrate infusion reduced bleeding after CABG without evidence of postoperative hypercoagulability. Larger studies are necessary to ensure safety and confirm efficacy of prophylactic fibrinogen treatment in cardiac surgery.

摘要

有人提出,术前血浆纤维蛋白原浓度与心脏手术后的术后失血独立相关。从理论上讲,预防性输注纤维蛋白原浓缩物可能会减少术后出血,但此前尚未对此进行研究。20例术前血浆纤维蛋白原水平<3.8 g/l的择期冠状动脉旁路移植术(CABG)患者被纳入一项前瞻性随机试点研究。患者被随机分为两组,一组在手术前接受2 g纤维蛋白原浓缩物输注(FIB组),另一组不进行输注(对照组)。主要终点是安全性,通过多层计算机断层扫描评估临床不良事件和移植血管闭塞情况。预定义的次要终点是术后失血量、输血情况、术后24小时(h)的血红蛋白水平,以及术后2小时和24小时用血栓弹力图评估的整体止血情况。输注2 g纤维蛋白原浓缩物使血浆纤维蛋白原水平升高了0.6±0.2 g/l。纤维蛋白原输注没有临床可检测到的不良事件。计算机断层扫描显示FIB组有1例亚临床静脉移植血管闭塞。纤维蛋白原浓缩物输注使术后失血量减少了32%(565±150 vs. 830±268 ml/12 h,p = 0.010)。FIB组术后24小时的血红蛋白浓度显著更高(110±12 vs. 98±8 g/l,p = 0.018)。通过血栓弹力图评估,预防性输注纤维蛋白原浓缩物对术后整体止血情况没有影响。总之,在这项试点研究中,术前输注纤维蛋白原浓缩物减少了CABG术后的出血,且没有术后高凝状态的证据。需要进行更大规模的研究以确保预防性纤维蛋白原治疗在心脏手术中的安全性并确认其疗效。

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