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 < .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.
Trial registration: ClinicalTrials.gov NCT00701142.