The use of recombinant activated factor VII in neurosurgery.
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.
Kapapa
Thomas
T
Department of Neurosurgery, Universitätsklinik Ulm, Ulm 89075, Germany.
König
Kathrin
K
Heissler
Hans E
HE
Schatzmann
Christiane
C
Tschan
Christoph A
CA
Perl
Michael
M
von Depka
Mario
M
Zumkeller
Matthias
M
Rickels
Eckhard
E
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
D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa