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 surgeryinvolving 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 < .001), -16.1 g/5 min after 1 transfusion cycle (fresh-frozen plasma or platelets; P = .003), and -28.0 g/5 min after 2 transfusion cycles (fresh-frozen plasma and platelets; P = .11). Reductions in bleeding rate were greater for patients with higher bleeding rates before treatment, especially with fibrinogen concentrate.

CONCLUSIONS:

FIBTEM-guided intraoperative hemostatic therapy with fibrinogen concentrate is more effective than placebo in controlling coagulopathic bleeding during major aortic replacement surgery. Fibrinogen concentrate is also more effective than 1 cycle of fresh-frozen plasma/platelets and is more rapid than-and at least as effective as-2 cycles of fresh-frozen plasma/platelets.