Estudio aleatorizado y doble ciego de profilaxis con fibrinógeno para reducir el sangrado en cirugía cardíaca

Mostafa Sadeghi , Reza Atefyekta , Omid Azimaraghi , Seyed Mojtaba Marashi , Yasaman Aghajani , Fatemeh Ghadimi , Donat R. Spahn , Ali Movafegh
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Abstract

Background and objectives

Postoperative bleeding has a great clinical importance and can contribute to increased mortality and morbidity in patients undergoing coronary artery bypass graft surgery. In this prospective, randomized, double-blind study, we evaluated the effect of prophylactic administration of fibrinogen concentrate on post-coronary artery bypass graft surgery bleeding.

Methods

A total of 60 patients undergoing coronary artery bypass surgery were randomly divided into two groups. Patients in the fibrinogen group received 1 g of fibrinogen concentrate 30 min prior to the operation, while patients in the control group received placebo. Post-operative bleeding volumes, prothrombin time, partial thromboplastin time, INR, hemoglobin and transfused blood products in both groups were recorded. A strict red blood cell transfusion protocol was used in all patients.

Results

There were no significant differences between intra-operative packed red blood cells infusion in the studied groups (1.0 ± 1.4 in fibrinogen group, and 1.3 ± 1.1 in control group). Less postoperative bleeding was observed in the fibrinogen group (477 ± 143 versus 703 ± 179, p = 0.0001). Fifteen patients in the fibrinogen group and 21 in the control group required post-op packed red blood cells infusion (p = 0.094). No thrombotic event was observed through 72 h after surgery.

Conclusion

Prophylactic fibrinogen reduces post-operative bleeding in patients undergoing coronary artery bypass graft.

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纤维蛋白原预防减少心脏手术出血的随机双盲研究
背景与目的术后出血具有重要的临床意义,可导致冠状动脉搭桥术患者死亡率和发病率的增加。在这项前瞻性、随机、双盲研究中,我们评估了预防性给予浓缩纤维蛋白原对冠状动脉搭桥术后出血的影响。方法将60例行冠状动脉搭桥术的患者随机分为两组。纤维蛋白原组患者在手术前30分钟给予浓缩纤维蛋白原1 g,对照组患者给予安慰剂。记录两组患者术后出血量、凝血酶原时间、部分凝血活酶时间、INR、血红蛋白及输注血制品。所有患者均采用严格的红细胞输注方案。结果两组患者术中灌注红细胞(纤维蛋白原组1.0±1.4,对照组1.3±1.1)差异无统计学意义。纤维蛋白原组术后出血较少(477±143 vs 703±179,p = 0.0001)。纤维蛋白原组15例,对照组21例,术后需要灌注红细胞(p = 0.094)。术后72 h未见血栓形成事件。结论预防性纤维蛋白原可减少冠状动脉搭桥术患者术后出血。
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