title: Recombinant FVIIa in the management of uncontrolled hemorrhage.
abstract: BACKGROUND
  Recombinant FVIIa (rFVIIa/NovoSeven) is a novel hemostatic agent originally developed to treat patients with hemophilia who had developed inhibitors. Several case reports have suggested that rFVIIa may be effective in treating patients without a pre-existing bleeding disorder who have uncontrolled bleeding.
  
  
  METHODS
  Data on the efficacy and safety of rFVIIa in the treatment of massive hemorrhage were obtained retrospectively from the NovoSeven extended-use data collection system.
  
  
  RESULTS
  A total of 40 patients received rFVIIa for uncontrolled bleeding, and in these patients, bleeding stopped or decreased in 32 (80%). Blood product usage was significantly decreased after rFVIIa administration. Thromboembolic events occurred in three patients with additional risk factors for thrombosis. Of 40 patients, 23 (57.5%) died. Bleeding was the direct cause of death in seven cases (all within 24 hr of administration of rFVIIa). The remaining 16 deaths were the result of sepsis, multi-organ failure, or the underlying disease.
  
  
  CONCLUSIONS
  In this retrospective study of data voluntarily submitted to a web-based drug surveillance program, we present preliminary results on the use of rFVIIa in nonhemophilia patients with bleeding. Although some efficacy is suggested, there was a high mortality rate from nonhemorrhagic causes. Randomized controlled trials are needed to properly assess the role of rFVIIa in the management of hemorrhage.
authors.affiliation: Katherine Dormandy Hemophilia Center, Royal Free and University College Medical School, London. n.o'connell@rfc.ucl.ac.uk
authors.forename: Niamh M
authors.initials: NM
authors.lastname: O'Connell
authors.forename: David J
authors.initials: DJ
authors.lastname: Perry
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Hodgson
authors.forename: Denise F
authors.initials: DF
authors.lastname: O'Shaughnessy
authors.forename: Michael A
authors.initials: MA
authors.lastname: Laffan
authors.forename: Owen P
authors.initials: OP
authors.lastname: Smith
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000933:Antifibrinolytic Agents / Q000627:therapeutic use; D016913:Blood Component Transfusion; D015942:Factor VIIa / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006454:Hemoglobins; D006470:Hemorrhage / Q000188:drug therapy* / Q000601:surgery; D006487:Hemostasis / Q000187:drug effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D000933:Antifibrinolytic Agents; D006454:Hemoglobins; D011994:Recombinant Proteins; D015942:Factor VIIa