Use of recombinant activated factor VII in severe post-partum haemorrhage: data from the Italian Registry: a multicentric observational retrospective study.

Purpose: To report the Italian real experience in clinical practice about recombinant factor VII activated (rFVIIa) in Post-Partum Haemorrhage (PPH) treatment.

Methods: An Italian retrospective survey of severe primary PPH cases treated with rFVIIa was performed. Anamnestic, clinical and haemostatic data about thirty-five patients with PPH, from 2005 to 2007, were collected. Coagulative parameters and transfusion requirements before and after rFVIIa treatment were compared.

Results: After rFVIIa administration INR was significantly decreased, while fibrinogen levels were markedly increased. Median of packed red blood cells units, platelets units, fresh frozen plasma, crystalloids and colloids needed, before and after rFVIIa administration, were respectively 6 and 2 units (p<1.2exp-6), 1.5 and 0 units (p=0.001), 1250 and 0 mL (p<4.4exp-5), 3000 and 1250 mL (p<0,0042). Twenty-nine of 35 patients needed surgical intervention before rFVIIa administration, 9/35 after treatment. Hysterectomies have been performed respectively in 10/35 cases before and in 6/35 cases after rFVIIa infusion. No maternal deaths have been reported. No adverse events or thromboembolic complications were observed.

Conclusions: Our clinical and haemostatic data suggest that recombinant activated factor VII may be a safe and helpful adjunctive therapy in the PPH management.