title: Use of recombinant activated factor VII (Novoseven) in trauma and surgery: analysis of outcomes reported to an international registry.
abstract: The objective was to evaluate the efficacy and safety of recombinant activated factor VII in patients with massive bleeding. Forty-five patients with severe massive hemorrhage requiring>or= 14 transfusion units of packed red blood cells received recombinant activated factor VII. Postdrug blood loss and transfusion requirements were assessed, and mortality was compared with predicted outcomes. Blood loss was markedly reduced in 40 of 43 (93.0%) patients, and transfusion requirements decreased after recombinant activated factor VII administration. Mortality rate in trauma patients who had massive hemorrhage was significantly reduced compared with predictions using scoring systems. This may be associated with the use of recombinant activated factor VII. This study failed to demonstrate an improvement in surgical patients. The absence of concurrent controls prevents definitive conclusions regarding actual safety or efficacy of recombinant activated factor VII.
authors.affiliation: Anaesthesia and Intensive Care Medicine, St George's Hospital, Tooting, London, UK. michael.grounds@stgeorges.nhs.uk
authors.forename: R Michael
authors.initials: RM
authors.lastname: Grounds
authors.forename: Caroline
authors.initials: C
authors.lastname: Seebach
authors.forename: Christoph
authors.initials: C
authors.lastname: Knothe
authors.forename: Piotr
authors.initials: P
authors.lastname: Paluszkiewicz
authors.forename: Terry S
authors.initials: TS
authors.lastname: Smith
authors.forename: Eduard
authors.initials: E
authors.lastname: Kasal
authors.forename: Ramon
authors.initials: R
authors.lastname: Lecumberri
authors.forename: Rene
authors.initials: R
authors.lastname: Urbanec
authors.forename: Thorsten
authors.initials: T
authors.lastname: Haas
authors.forename: Maria
authors.initials: M
authors.lastname: Wujtewicz
authors.forename: Dagmar
authors.initials: D
authors.lastname: Rehorkova
authors.forename: Martina
authors.initials: M
authors.lastname: Pelichovska
authors.forename: Martina
authors.initials: M
authors.lastname: Lange
authors.forename: Maite
authors.initials: M
authors.lastname: Uranga
authors.forename: Roman
authors.initials: R
authors.lastname: Bosman
authors.forename: J Hans
authors.initials: JH
authors.lastname: Rommes
authors.forename: Juergen
authors.initials: J
authors.lastname: Koscielny
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D016063:Blood Loss, Surgical / Q000517:prevention & control*; D002170:Canada; D004305:Dose-Response Relationship, Drug; D005060:Europe; D015942:Factor VIIa / Q000627:therapeutic use*; D005260:Female; D006470:Hemorrhage / Q000188:drug therapy* / Q000209:etiology*; D006489:Hemostatic Techniques; D006801:Humans; D015601:Injury Severity Score; D008297:Male; D008875:Middle Aged; D012042:Registries; D018570:Risk Assessment / Q000379:methods; D016019:Survival Analysis; D016896:Treatment Outcome; D014947:Wounds and Injuries / Q000145:classification / Q000150:complications*
chemical_list: D015942:Factor VIIa