title: Failure of recombinant factor VIIa in a patient with severe polymicrobial sepsis and postoperative uncontrolled intraabdominal bleeding.
abstract: BACKGROUND
  This report discusses a case of unsuccessful treatment with recombinant factor VIIa (rFVIIa) in off-label use. The need for international guidelines concerning the off-label use of rFVIIa is outlined as well as the need for methods to control the efficacy of rFVIIa objectively.
  
  
  METHODS
  54 year old male with severe polymicrobial sepsis due to a perforated diverticulitis of the sigmoid colon and consecutive overt disseminated intravascular coagulation. He suffered severe intraabdominal bleeding after abdominal surgery despite conventional haemostatic support. Repeated applications of factor VIIa temporarily improved coagulation essays but did not stop clinical bleeding. The patient died in multiorgan failure due to septic and haemorrhagic shock.
  
  
  CONCLUSIONS
  Off-label use of rFVIIa could result in more side effects than could be expected from literature because of a publication bias. However for most off-label applications large prospective, randomised and controlled trials to confirm the positive findings are missing. For the future, not only guidelines concerning the off-label use of rFVIIa are urgently needed but also guidelines for monitoring the efficacy of rFVIIa.
authors.affiliation: Department of Infectious Diseases, University Hospital, Basel, Switzerland. conena@uhbs.ch
authors.forename: Anna
authors.initials: A
authors.lastname: Conen
authors.forename: Maja
authors.initials: M
authors.lastname: Weisser
authors.forename: Dimitrios A
authors.initials: DA
authors.lastname: Tsakiris
authors.forename: Martin
authors.initials: M
authors.lastname: Siegemund
mesh_terms: D000005:Abdomen; D003029:Coagulants / Q000627:therapeutic use*; D015942:Factor VIIa / Q000235:genetics / Q000627:therapeutic use*; D017809:Fatal Outcome; D006801:Humans; D008297:Male; D008875:Middle Aged; D019106:Postoperative Hemorrhage / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000382:microbiology; D011860:Radiography, Abdominal; D011994:Recombinant Proteins / Q000627:therapeutic use; D018805:Sepsis / Q000382:microbiology / Q000601:surgery*; D014057:Tomography, X-Ray Computed; D017211:Treatment Failure
chemical_list: D003029:Coagulants; D011994:Recombinant Proteins; D015942:Factor VIIa