Use of Recombinant Activated Factor VII in Severe Postpartum Haemorrhage: Data from the South European Registry. A Multicentric Observational Retrospective Study

Introduction: Major Post Partum Haemorrhage (PPH) is a life threatening complication of labor, which mainly occurs without warning, predictive signs and symptoms and often in absence of predisposing conditions. A retrospective survey of cases of severe primary PPH treated with Recombinant Activated Factor VII (rFVIIa) in Italy, Greece, Spain and Portugal was performed. The aim of our study was to report the south european real experience in clinical practice about the use rFVIIa in PPH treatment.

Methods: anamnestic, clinical and haemostatic data about fortyfive patients, treated between 2005 and 2007, were collected. Coagulative parameters and transfusion requirements before and after rFVIIa treatment were compared.

Results: INR significantly decreased, while levels of fibrinogen markedly increased after rFVIIa administration. The median need of packed red blood cells units, platelets units, fresh frozen plasma and crystalloids and colloids, before and after rFVIIa administration, dramatically reduced being 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 1250mL (p<0,0042). No cases of adverse effects 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 management of postpartum haemorrhage.