title: Recombinant activated factor VIIa for the treatment of bleeding in major abdominal surgery including vascular and urological surgery: a review and meta-analysis of published data.
abstract: BACKGROUND
  The purpose of this study was to determine the role of recombinant activated factor VII (rFVIIa) in abdominal, vascular, and urological surgery.
  
  
  METHODS
  We conducted meta-analyses of case series and placebo-controlled studies reporting on the treatment or prophylaxis of bleeding with rFVIIa regarding 'reduction or cessation of bleeding', 'mortality', and 'thromboembolism'.
  
  
  RESULTS
  All case reports (n = 15 case reports and 17 patients) documented an effect of rFVIIa in the treatment of bleeding. A meta-analysis of 10 case series revealed a reduction or cessation of bleeding in 39 out of 50 patients after administration of rFVIIa (estimated mean effect 73.2%, 95% confidence interval [CI] 51.0% to 95.4%) and a mean probability of survival of 53.0% (95% CI 26.4% to 79.7%). Among the rFVIIa responders, 19 out of 29 patients (66%) survived versus 1 out of 10 rFVIIa nonresponders (P = 0.003). Six out of 36 patients from the case series had a thromboembolic complication (estimated mean probability 16.5%, 95% CI 1.2% to 31.8%). Compared with a meta-analysis of eight placebo-controlled studies, no increased risk of thromboembolism was seen after administration of rFVIIa.
  
  
  CONCLUSIONS
  The meta-analysis of case series showed that, in a mean of 73% patients, rFVIIa achieved at least a reduction of bleeding and that the probability of survival is increased in patients responding to rFVIIa. rFVIIa was not associated with an increased risk of thromboembolism compared with placebo.
authors.affiliation: Department of Anesthesiology and Intensive Care Medicine, Charité-University Medicine Berlin, Campus Virchow-Klinikum and Campus Charité Mitte, Augustenburger Platz 1, 13353 Berlin, Germany. christian.von_heymann@charite.de
authors.forename: Christian
authors.initials: C
authors.lastname: von Heymann
authors.forename: Sven
authors.initials: S
authors.lastname: Jonas
authors.forename: Claudia
authors.initials: C
authors.lastname: Spies
authors.forename: Klaus-Dieter
authors.initials: KD
authors.lastname: Wernecke
authors.forename: Sabine
authors.initials: S
authors.lastname: Ziemer
authors.forename: Detlev
authors.initials: D
authors.lastname: Janssen
authors.forename: Jürgen
authors.initials: J
authors.lastname: Koscielny
mesh_terms: D000005:Abdomen / Q000601:surgery; D013504:Cardiovascular Surgical Procedures; D015942:Factor VIIa / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007431:Intraoperative Complications / Q000188:drug therapy*; D008297:Male; D019106:Postoperative Hemorrhage / Q000188:drug therapy / Q000401:mortality / Q000517:prevention & control*; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D013923:Thromboembolism / Q000139:chemically induced; D014570:Urologic Diseases / Q000601:surgery
chemical_list: D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa