title: Variation in the use of recombinant activated factor VII in critical bleeding.
abstract: BACKGROUND
  Recombinant activated factor VII (rFVIIa) is being increasingly used as a treatment option in settings of uncontrolled bleeding. Despite this, national practice guidelines are lacking, resulting in widespread practice variation between providers. This investigation aimed to describe the differences in use of rFVIIa across Australian and New Zealand hospitals.
  
  
  METHODS
  Data were extracted from the Haemostasis Registry that collects both contemporaneous and retrospective cases of off-licence (i.e. in non-haemophilia patients) rFVIIa use in participating institutions. Hospitals were classified according to geographical location and service provision.
  
  
  RESULTS
  2075 cases from 87 hospitals were recorded on the Haemostasis Registry. Across all hospital categories, over 41% of cases received rFVIIa in relation to cardiac surgery. Case complexity varied between providers, with large urban centres treating more severely ill patients. This was reflected in significant differences in the use of blood components and products before rFVIIa administration. Despite differences in patient complexity and use of blood products between hospital categories, response to treatment and patient outcomes remained similar across providers, with survival rates ranging from 68.29% to 70.41%.
  
  
  CONCLUSIONS
  This is the largest study of off-licence use of rFVIIa. There is significant regional variation in the administration of rFVIIa in Australian and New Zealand hospitals, with little documentation of adherence to guidelines. National consensus guidelines based on available evidence should be developed and promulgated to ensure optimal outcomes.
authors.affiliation: Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria 3004, Australia.
authors.forename: C D
authors.initials: CD
authors.lastname: Willis
authors.forename: P A
authors.initials: PA
authors.lastname: Cameron
authors.forename: L
authors.initials: L
authors.lastname: Phillips
mesh_terms: D000328:Adult; D000368:Aged; D001315:Australia / Q000453:epidemiology; D004363:Drug Utilization / Q000639:trends; D015942:Factor VIIa / Q000627:therapeutic use*; D005260:Female; D006470:Hemorrhage / Q000188:drug therapy* / Q000453:epidemiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009520:New Zealand / Q000453:epidemiology; D056687:Off-Label Use; D011994:Recombinant Proteins / Q000627:therapeutic use; D012042:Registries; D012189:Retrospective Studies
chemical_list: D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa