National audit of the use of fibrinogen concentrate to correct hypofibrinogenaemia

Abstract

Massive haemorrhage occurs in a variety of clinical settings resulting in consumptive and dilutional coagulopathies leading to hypofibrinogenaemia. A prospective observational national cohort study was performed between November 2008 and June 2010 to collect safety data on the off-label use of a fibrinogen concentrate to treat acquired hypofibrinogenaemia. A prospective cohort of 63 patients with varying causes of hypofibrinogenaemia resulted from this data collection. A single infusion of fibrinogen concentrate was given in 49 (77%) of patients studied and 12 received more than one infusion. The median inter-quartile range (IQR) dose of fibrinogen infused was 49 (26-61) mg kg(-1). The median (IQR) fibrinogen level before and after infusion was 0.9 (0.6-1.3) and 1.8 (1.4-4.3) g L(-1), respectively (P < 0.001). In 31 patients (67%), bleeding stopped within 4 h and fibrinogen was reported to have contributed to this outcome by the treating clinicians. In 84% of cases the treating clinician reported that the use of fibrinogen concentrate reduced the rate of bleeding. Fibrinogen was associated with a statistically significant reduction in red blood cell transfusion (median 4 units before and 0 units after, P < 0.001) and fresh frozen plasma infusion (median 4 units before and 0 units after, P < 0.001). Three venous and one arterial non-fatal thrombotic events were recorded in the patients treated with fibrinogen. Fibrinogen concentrate can be used to correct hypofibrinogenaemia and may reduce blood product usage.