title: The use of recombinant activated factor VII in neurosurgery.
abstract: BACKGROUND
  Bleeding complications in neurosurgery often take alarming proportions without major hemodynamic effect or impairment of coagulation physiology because severe neurologic deficits are to be expected. Any measures used to stabilize or normalize coagulation are therefore of great interest. Administration of packed red cells, fresh frozen plasma, and platelet concentrates is associated with volume loading, which is suspected to multiply the secondary brain damage, for example, by the development of an edema. In this respect, the administration of rFVIIa may develop into a new option associated with low-volume administration.
  
  
  METHODS
  We report on 5 neurosurgical patients to whom rFVIIa was given at doses of 51 to 202 microg/kg of body weight for the treatment of severe intraoperative bleeding (n = 3) or as prophylaxis of bleeding (n = 2). The operation was completed successfully in all patients after administration of rFVIIa, with stabilization of the coagulation status.
  
  
  CONCLUSIONS
  Therefore, reported cases constitute an approach in treatment and prophylaxis of bleeding complications in neurosurgery. There are reports of thromboembolic events in use of rFVIIa, particularly in unlabeled use. But according to our findings and current literature, there is no evidence of higher risk of thromboembolic adverse events in treatment with rFVIIa. However, the number of patients presented does not allow any final assessment to be made as to whether the properties of rFVIIa are of particular benefit for neurosurgical patients. Further studies with appropriate study design are required to verify effects observed in this investigation.
authors.affiliation: Department of Neurosurgery, Universitätsklinik Ulm, Ulm 89075, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Kapapa
authors.forename: Kathrin
authors.initials: K
authors.lastname: König
authors.forename: Hans E
authors.initials: HE
authors.lastname: Heissler
authors.forename: Christiane
authors.initials: C
authors.lastname: Schatzmann
authors.forename: Christoph A
authors.initials: CA
authors.lastname: Tschan
authors.forename: Michael
authors.initials: M
authors.lastname: Perl
authors.forename: Mario
authors.initials: M
authors.lastname: von Depka
authors.forename: Matthias
authors.initials: M
authors.lastname: Zumkeller
authors.forename: Eckhard
authors.initials: E
authors.lastname: Rickels
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016063:Blood Loss, Surgical / Q000517:prevention & control*; D001927:Brain Diseases / Q000601:surgery*; D005168:Factor VII Deficiency / Q000150:complications* / Q000601:surgery; D015942:Factor VIIa / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D011994:Recombinant Proteins / Q000627:therapeutic use; D013122:Spinal Diseases / Q000601:surgery*; D055815:Young Adult
chemical_list: D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa