title: A critical review on the use of recombinant factor VIIa in life-threatening obstetric postpartum hemorrhage.
abstract: The objective of this review was to evaluate and summarize the current literature on the unlicensed use of the novel agent recombinant activated factor VII (rFVIIa) in the management of major postpartum hemorrhage. After a systematic electronic search without temporal limits on MEDLINE, EMBASE, OVID and SCOPUS, the bibliographic references of all retrieved studies and reviews were additionally assessed for further reports of clinical trials. Unpublished works were also identified by searching abstracts from the most eminent conferences on this topic. In total, there were 31 studies that fulfilled our inclusion criteria. These studies incorporated 118 cases of massive postpartum hemorrhage treated with rFVIIa. The median age of the patients was 31.4 years, and cesarean section appeared to increase the risk of postpartum hemorrhage. At a median dose of 71.6 mug/kg, rFVIIa was reported to be effective in stopping or reducing bleeding in nearly 90% of the reported cases. Based on the evidence from the literature, we give some recommendations on the use of rFVIIa in massive postpartum hemorrhage. Nevertheless, although these reports suggest the potential role of rFVIIa in treating massive postpartum hemorrhage refractory to standard therapy, we advise particular caution in interpreting these results, as they are derived from few and uncontrolled studies. Further evidence is needed using well-designed clinical trials to better assess the optimal dose, the effectiveness, and the safety of rFVIIa in such critical bleeding conditions.
authors.affiliation: Servizio di Immunoematologia e Trasfusione - Centro Emofilia, Azienda Ospedaliera di Verona, Verona; Italy. massimo.franchini@azosp.vr.it
authors.forename: Massimo
authors.initials: M
authors.lastname: Franchini
authors.forename: Massimo
authors.initials: M
authors.lastname: Franchi
authors.forename: Valentino
authors.initials: V
authors.lastname: Bergamini
authors.forename: Gian Luca
authors.initials: GL
authors.lastname: Salvagno
authors.forename: Martina
authors.initials: M
authors.lastname: Montagnana
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Lippi
mesh_terms: D000328:Adult; D000465:Algorithms; D002985:Clinical Protocols; D002986:Clinical Trials as Topic; D016638:Critical Illness; D015942:Factor VIIa / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D006473:Postpartum Hemorrhage / Q000097:blood / Q000188:drug therapy*; D011247:Pregnancy; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D012449:Safety
chemical_list: D011994:Recombinant Proteins; D015942:Factor VIIa