Gomes Manuela, Ângelo-Dias Miguel, Lima Jorge
Transfusion Medicine Department, Hemovida, Hospital da Luz Lisboa, Luz Saúde, 1500-650 Lisboa, Portugal.
NOVA Medical School, Faculdade de Ciências Médicas, NMS, FCM, Universidade Nova de Lisboa, 1169-056 Lisboa, Portugal.
J Clin Med. 2024 Oct 9;13(19):6018. doi: 10.3390/jcm13196018.
Surgery often leads to bleeding associated with hypofibrinogenemia. Supplementation with fibrinogen concentrate appears to be effective and safe, although findings from studies are inconsistent. The primary aim of this study was to assess the safety of fibrinogen concentrate during the perioperative period. This single-centre, prospective, observational study included adult patients undergoing scheduled or emergency surgery related to bleeding coagulopathy and the administration of fibrinogen concentrate. Patients were followed until their discharge from the institution. Comprehensive data were collected, including age, sex, type of surgery, associated comorbidities, anticoagulant and/or anti-aggregating therapy, and the number of blood transfusions. Laboratory data on plasma fibrinogen concentration, haemoglobin, and platelet count before and after surgery were also collected. The primary outcomes were the mortality rate at discharge and any reported thrombotic or thromboembolic events, including deep vein thrombosis, pulmonary embolism, and myocardial infarction. The study included 91 adult patients who had undergone surgery, with 29 surgeries (32%) conducted in an emergency setting. The mean age was 59.2 years, and 53.8% were male. Major bleeding occurred in 29 cases, mainly in older males and those on anticoagulant therapy. The pre-operative fibrinogen level averaged 161 mg/dL, and the average dosage of fibrinogen concentrate administered was 2.7 g. Eight patients died (8.8%), mostly due to septic or cardiogenic shock, with deaths being more frequent in emergency settings. Thromboembolic events occurred in eight patients, none of whom died. No additional adverse events directly related to the administration of fibrinogen concentrate were reported. Our findings suggest a favourable safety profile for fibrinogen concentrate in surgical patients, as evidenced by a low incidence of deaths and thromboembolic events, which were primarily attributed to other factors. Future research should strive to increase statistical robustness to further illuminate clinically significant patient safety measures.
手术常常导致与低纤维蛋白原血症相关的出血。尽管研究结果并不一致，但补充纤维蛋白原浓缩物似乎是有效且安全的。本研究的主要目的是评估围手术期使用纤维蛋白原浓缩物的安全性。这项单中心、前瞻性观察性研究纳入了因出血性凝血病接受择期或急诊手术并使用纤维蛋白原浓缩物的成年患者。对患者进行随访直至其出院。收集了全面的数据，包括年龄、性别、手术类型、相关合并症、抗凝和/或抗聚集治疗以及输血次数。还收集了手术前后血浆纤维蛋白原浓度、血红蛋白和血小板计数的实验室数据。主要结局是出院时的死亡率以及任何报告的血栓形成或血栓栓塞事件，包括深静脉血栓形成、肺栓塞和心肌梗死。该研究纳入了91例接受手术的成年患者，其中29例手术（32%）在急诊情况下进行。平均年龄为59.2岁，男性占53.8%。29例发生大出血，主要见于老年男性和接受抗凝治疗的患者。术前纤维蛋白原水平平均为161mg/dL，纤维蛋白原浓缩物的平均给药剂量为2.7g。8例患者死亡（8.8%），主要死于感染性或心源性休克，急诊情况下死亡更为常见。8例患者发生血栓栓塞事件，均未死亡。未报告与纤维蛋白原浓缩物给药直接相关的其他不良事件。我们的研究结果表明，纤维蛋白原浓缩物在手术患者中具有良好的安全性，死亡和血栓栓塞事件发生率低证明了这一点，这些事件主要归因于其他因素。未来的研究应努力提高统计稳健性，以进一步阐明具有临床意义的患者安全措施。
