Fibrinogen concentrate reduces intraoperative bleeding when used as first-line hemostatic therapy during major aortic replacement surgery: Results from a randomized, placebo-controlled trial

Objectives We assessed whether fibrinogen concentrate as targeted first-line hemostatic therapy was more effective than placebo or a standardized transfusion algorithm in controlling coagulopathic bleeding in patients undergoing major aortic surgery. Methods In this single-center, prospective, double-blind study, adults undergoing elective thoracic or thoracoabdominal aortic replacement surgery involving cardiopulmonary bypass were randomized to intraoperative fibrinogen concentrate (n = 29) or placebo (n = 32). Study medication was given if patients had clinically relevant coagulopathic bleeding, measured by 5-minute bleeding mass, after cardiopulmonary bypass removal, protamine administration, and surgical hemostasis. Fibrinogen concentrate dosing was individualized using the thromboelastometric FIBTEM test. If bleeding continued, a standardized transfusion algorithm was followed. In the placebo group, all 32 patients received 1 transfusion cycle of fresh-frozen plasma/platelets, and 30 patients required a second transfusion cycle; none of these patients received any other procoagulant therapy. Change in bleeding rate after treatment was compared using t tests. Results Mean change in bleeding rate after fibrinogen concentrate was −48.3 g/5 min, compared with 0.4 g/5 min after placebo ( P