Safety and efficacy of fibrinogen concentrate in aortic arch surgery involving moderate hypothermic circulatory arrest.

Abstract

Bleeding is a common complication of cardiac surgery, especially aortic arch surgery involving moderate hypothermic circulatory arrest. Fibrinogen concentrate has been increasingly used to treat coagulopathic bleeding in cardiac surgery, although its effectiveness and safety are unknown. The aim of this prospective study was to investigate the safety and efficacy of fibrinogen concentrate in patients with acute type A aortic dissection. From July 2020 to August 2021, 84 patients with acute type A aortic dissection who underwent emergency aortic arch surgery involving MHCA and whose intraoperative fibrinogen level was less than 1.5g/L were included in this study. Fifty-four patients who were supplemented with fibrinogen concentrate were included in the FC treatment group. Thirty patients were included in the non-FC treatment group. The primary endpoints included the required volumes of individual allogeneic blood products (RBCs, FFP, and PC), volumes of cumulative drainage within 24 and 48h, and total volumes after infusion of FC, as well as reoperation rates due to bleeding. The secondary endpoint for the study was the incidence of serious adverse events from the infusion of FC to day 45. The serious adverse events defined for the evaluation of the safety of FC were death, pulmonary embolism and other thromboembolic or ischaemic events. The clinical data, routine laboratory tests and plasma fibrinogen levels were obtained at 5 time points. We observed rapid increases in the plasma fibrinogen level and subsequent improvement in haemostasis after the administration of fibrinogen concentrate. The mean fibrinogen level increased from 1.36 ± 0.75g/L to 2.91 ± 0.76g/L in the fibrinogen concentrate treatment group. The patients in the fibrinogen concentrate treatment group demonstrated lower volumes of cumulative postoperative drainage and transfused allogeneic blood products than the nonfibrinogen concentrate treatment group. There were no serious adverse events in the fibrinogen concentrate treatment group during hospitalization. Fibrinogen concentrate was effective at increasing the plasma fibrinogen level and significantly reduced the volumes of transfused allogeneic blood products and blood loss in patients with aortic arch surgery. There were no serious adverse events in the patients who received fibrinogen concentrate treatment. The safety and efficacy of fibrinogen concentrate were investigated in acute type A aortic dissection patients with aortic arch surgery. Fibrinogen concentrate was effective at increasing the plasma fibrinogen level and significantly reduced the volumes of transfused allogeneic blood products and blood loss; there were no serious adverse events in the patients who received fibrinogen concentrate treatment.