OBJECTIVES: Fibrinogen concentrate increasingly is used to treat coagulopathic bleeding in cardiac surgery although its effectiveness and safety have not been shown. The authors conducted a cohort study to quantify the effects of fibrinogen concentrate on postoperative blood loss and transfusion and the occurrence of adverse clinical events in complex cardiac surgery patients. DESIGN: A cohort analysis using prospectively collected data. SETTING: A teaching hospital. PARTICIPANTS: One thousand seventy-five patients who underwent complex cardiac surgery in the years 2007 to 2010. INTERVENTION: A nonrandomized intervention with fibrinogen concentrate during complex cardiac surgery. MEASUREMENTS AND MAIN RESULTS: Of the 1,075 patients, 264 (25%) received fibrinogen concentrate during surgery (median dose = 2 g). In the adjusted analysis, the effect of fibrinogen concentrate on blood loss and transfusion in the intensive care unit showed a ratio of geometric means of 1.02 (0.91-1.14) and an odds ratio of 1.14 (0.83-1.56), respectively. For the risk of 30-day mortality, myocardial infarction, cerebrovascular accident/transient ischemic attack, renal insufficiency/failure, total infections, and prolonged mechanical ventilation the adjusted odds ratios were 0.96 (0.48-1.92), 1.10 (0.53-2.27), 1.16 (0.50-2.72), 0.62 (0.29-1.32), 1.18 (0.72-1.95), and 1.44 (0.83-2.49), respectively. CONCLUSIONS: Fibrinogen concentrate infusion during surgery did not reduce postoperative blood loss and transfusion, and no increased risk for clinical adverse events was measured. The lower doses and the relatively late intervention with fibrinogen concentrate might have attenuated its hemostatic effect. This study reports the initial clinical use of fibrinogen concentrate in complex cardiac surgery. A randomized clinical trial has been initiated to investigate the hemostatic role of fibrinogen concentrate in cardiac surgery.
OBJECTIVES:Fibrinogen concentrate increasingly is used to treat coagulopathic bleeding in cardiac surgery although its effectiveness and safety have not been shown. The authors conducted a cohort study to quantify the effects of fibrinogen concentrate on postoperative blood loss and transfusion and the occurrence of adverse clinical events in complex cardiac surgery patients. DESIGN: A cohort analysis using prospectively collected data. SETTING: A teaching hospital. PARTICIPANTS: One thousand seventy-five patients who underwent complex cardiac surgery in the years 2007 to 2010. INTERVENTION: A nonrandomized intervention with fibrinogen concentrate during complex cardiac surgery. MEASUREMENTS AND MAIN RESULTS: Of the 1,075 patients, 264 (25%) received fibrinogen concentrate during surgery (median dose = 2 g). In the adjusted analysis, the effect of fibrinogen concentrate on blood loss and transfusion in the intensive care unit showed a ratio of geometric means of 1.02 (0.91-1.14) and an odds ratio of 1.14 (0.83-1.56), respectively. For the risk of 30-day mortality, myocardial infarction, cerebrovascular accident/transient ischemic attack, renal insufficiency/failure, total infections, and prolonged mechanical ventilation the adjusted odds ratios were 0.96 (0.48-1.92), 1.10 (0.53-2.27), 1.16 (0.50-2.72), 0.62 (0.29-1.32), 1.18 (0.72-1.95), and 1.44 (0.83-2.49), respectively. CONCLUSIONS:Fibrinogen concentrate infusion during surgery did not reduce postoperative blood loss and transfusion, and no increased risk for clinical adverse events was measured. The lower doses and the relatively late intervention with fibrinogen concentrate might have attenuated its hemostatic effect. This study reports the initial clinical use of fibrinogen concentrate in complex cardiac surgery. A randomized clinical trial has been initiated to investigate the hemostatic role of fibrinogen concentrate in cardiac surgery.