Department of Anaesthesia, Surgical Intensive Care, Prehospital Emergency Medicine and Pain Therapy and.
Department of Anaesthesia, Surgical Intensive Care, Prehospital Emergency Medicine and Pain Therapy and Institute of Anesthesiology, Cantonal Hospital, St Gallen, Switzerland.
Br J Anaesth. 2015 Feb;114(2):225-34. doi: 10.1093/bja/aeu364. Epub 2014 Oct 16.
Although infusion of fibrinogen concentrate is increasingly used in bleeding patients after cardiac surgery, safety data are scarce. We aimed to evaluate the effect of perioperative administration of fibrinogen concentrate on postoperative morbidity and mortality in patients undergoing cardiac surgery.
During a 2 yr study period, 991 patients underwent cardiac surgery at a single university centre and were eligible for propensity score (PS) matching. We matched 190 patients with perioperative infusion of fibrinogen concentrate (median dose 2 g) with 190 controls without fibrinogen administration. After PS matching, crude outcome was analysed. Further, a multivariate logistic regression including additional risk factors for adverse outcome was performed. The primary endpoint was a composite of mortality and the occurrence of major cardiac and thromboembolic events within 1 yr. Secondary outcomes included mortality after 30 days and 1 yr and the composite of mortality and adverse events after 30 days.
The administration of fibrinogen concentrate was not associated with an increased risk for mortality and thromboembolic or cardiac events within 1 yr after cardiac surgery [unadjusted hazard ratio (HR) 0.91; 95% confidence interval (CI) 0.55-1.49; P=0.697]. When using multivariate logistic regression model, the HR for adverse outcome in patients with administration of fibrinogen concentrate was 0.57 (95% CI 0.25-1.17; P=0.101). Similarly, the administration of fibrinogen concentrate did not adversely affect the secondary outcomes when applying unadjusted and multivariate regression analyses.
Our study strongly suggests that the administration of fibrinogen concentrates at low dose is not associated with thromboembolic complications or adverse outcomes after cardiac surgery.
尽管纤维蛋白原浓缩物输注在心脏手术后出血患者中越来越多地被使用，但安全性数据仍然缺乏。我们旨在评估心脏手术后围手术期给予纤维蛋白原浓缩物对术后发病率和死亡率的影响。
在为期 2 年的研究期间，991 例患者在一家大学中心接受了心脏手术，符合倾向评分（PS）匹配条件。我们将 190 例接受围手术期纤维蛋白原浓缩物输注（中位数剂量 2 g）的患者与 190 例未给予纤维蛋白原的对照患者进行了 PS 匹配。PS 匹配后，分析了粗结局。此外，还进行了多变量逻辑回归分析，纳入了不良结局的其他危险因素。主要终点是 1 年内死亡率和主要心脏及血栓栓塞事件的复合发生率。次要结局包括 30 天和 1 年死亡率以及 30 天内死亡率和不良事件的复合发生率。
心脏手术后 1 年内，给予纤维蛋白原浓缩物与死亡率及血栓栓塞或心脏事件的风险增加无关[未调整的危险比（HR）0.91；95%置信区间（CI）0.55-1.49；P=0.697]。当使用多变量逻辑回归模型时，给予纤维蛋白原浓缩物的患者不良结局的 HR 为 0.57（95%CI 0.25-1.17；P=0.101）。同样，当应用未调整和多变量回归分析时，给予纤维蛋白原浓缩物也不会对次要结局产生不利影响。
我们的研究强烈表明，低剂量给予纤维蛋白原浓缩物与心脏手术后的血栓栓塞并发症或不良结局无关。
