Recombinant Activated Factor VII as a Second Line Treatment for Postpartum Hemorrhage

Abstract

Background Severe or massive postpartum hemorrhage (PPH) has remained a leading cause of maternal mortality for decades across the world and it results in critical obstetric complications. Recombinant activated factor VII (rFVIIa) has emerged as a gold standard adjunctive hemostatic agent for the treatment of life-threatening PPH refractory to conventional therapies although it remains off-licensed for use in PPH. We studied the effects of rFVIIa on coagulopathy, transfusion volume, prognosis, severity change in Korean PPH patients. Methods A retrospective review of medical records between December 2008 and March 2011 indicating use of rFVIIa in severe PPH was performed. We compared age, rFVIIa treatment, transfusion volume, and Sequential Organ Failure Assessment (SOFA) score at the time of arrival in the emergency department and after 24 hours for patients whose SOFA score was 8 points or higher. Results Fifteen women with SOFA score of 8 and above participated in this study and eight received rFVIIa administration whereas seven did not. Patients’ mean age was 31.7 ± 7.5 years. There was no statistically significant difference in initial and post-24 hours SOFA scores between patients administered rFVIIa or not. The change in SOFA score between initial presentation and after 24 hours was significantly reduced after rFVIIa administration (P = 0.016). Conclusions This analysis aimed to support that the administration of rFVIIa can reduce the severity of life-threatening PPH in patients. A rapid decision regarding the administration of rFVIIa is needed for a more favorable outcome in severe PPH patients for whom there is no effective standard treatment.

Keywords

• factor VIIa
• maternal death
• organ dysfunction scores
• postpartum hemorrhage
• recombinant proteins