Observational study of fibrinogen concentrate in massive hemorrhage: evaluation of a multicenter register.

In acute hemorrhage, a critical decrease in fibrinogen often induces acquired coagulopathy. Fibrinogen concentrate has been used to supplement fibrinogen during massive hemorrhage. However, there are limited data on the utilization of fibrinogen concentrate in this setting. This prospective, multicenter observational study analyzed clinical treatment with fibrinogen concentrate in acute bleeding. A prospective multicenter web-based register was developed to document closed cases of massive hemorrhage treated with fibrinogen concentrate perioperatively. Anonymized data including the cause and kinetics of the bleeding, coagulation parameters, coagulation therapy, clinical effects and adverse events were recorded. Two hundred and twenty-three cases entered between September 2008 and August 2009 were eligible for analysis. According to patient needs, additional common blood and coagulation products were administered. Fibrinogen substitution by fibrinogen concentrate and fresh frozen plasma (FFP) was initiated at a median blood loss of 2.0 l and plasma fibrinogen of 1.45 g/l. After a median dose of 12.0 g fibrinogen (4 g in fibrinogen concentrate and 8 g in FFP), plasma fibrinogen rose to 2.19 g/l at the end of surgery; corresponding to a median increment of 0.045 g/l per gram of fibrinogen administered. After substitution, 6% of patients had supra-physiological plasma fibrinogen levels. Three percent of patients sustained thromboembolic complications perioperatively. Logistic regression analysis showed positive correlation of postoperative plasma fibrinogen and survival (P < 0.05). Clinical application of fibrinogen concentrate in bleeding patients is included within a multimodal therapeutic concept. High levels of fibrinogen are necessary in order to reach therapeutic goals. In bleeding patients, higher plasma fibrinogen might be associated with higher rates of survival.