Recombinant factor VIIa for rapid reversal of warfarin anticoagulation in acute intracranial hemorrhage.
OBJECTIVE
To assess the effects of recombinant factor VIIa (rFVIIa) on hemorrhage volume and functional outcomes in warfarin-related acute intracranial hemorrhage (ICH), which has a 30-day mortality of more than 50%.


METHODS
We reviewed the clinical, laboratory, and radiographic features of a consecutive series of 7 patients (median age, 87 years; 5 women) with symptomatic, nontraumatic warfarin-related acute ICH treated with intravenous rFVIIa at St. Luke's Hospital in Jacksonville, Fla, between December 2002 and September 2003. Prestroke baseline functional status was assessed with the modified Rankin Scale. Outcome was assessed with the Glasgow Outcome Scale.


RESULTS
The international normalized ratio decreased from a mean of 2.7 before administration of rFVIIa to 1.08 after administration of rFVIIa. The median prestroke score on the modified Rankin Scale was zero. The median presenting score on the Glasgow Coma Scale was 14 (range, 4-15). The mean time from onset to treatment was 6.2 hours. The mean initial dose of rFVIIa was 62.1 microg/kg. One patient underwent placement of an external ventricular drain, and another underwent craniotomy and hematoma evacuation. Five of the 7 patients survived and were dismissed from the hospital with severe disability (Glasgow Outcome Scale, 3); 2 patients died during hospitalization.


CONCLUSIONS
Intravenous bolus administration of rFVIIa can rapidly lower the international normalized ratio and appears to be safe for patients with warfarin-related ICH. Prospective controlled studies are needed to determine whether rFVIIa can prevent hematoma expansion and improve neurologic outcomes in patients with warfarin-related ICH.
Freeman
William D
WD
Department of Neurology, Mayo Clinic College of Medicine, Jacksonville, Fla 32224, USA.
Brott
Thomas G
TG
Barrett
Kevin M
KM
Castillo
Pablo R
PR
Deen
H Gordon
HG
Czervionke
Leo F
LF
Meschia
James F
JF
D000208:Acute Disease; D000368:Aged; D000369:Aged, 80 and over; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005167:Factor VII / Q000008:administration & dosage*; D015942:Factor VIIa; D005260:Female; D005500:Follow-Up Studies; D015600:Glasgow Coma Scale; D006801:Humans; D007262:Infusions, Intravenous; D019934:International Normalized Ratio; D020300:Intracranial Hemorrhages / Q000139:chemically induced* / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D011994:Recombinant Proteins / Q000008:administration & dosage*; D012189:Retrospective Studies; D018570:Risk Assessment; D012494:Sampling Studies; D012720:Severity of Illness Index; D015996:Survival Rate; D016896:Treatment Outcome; D014859:Warfarin / Q000009:adverse effects* / Q000627:therapeutic use
D011994:Recombinant Proteins; D014859:Warfarin; D005167:Factor VII; C103587:recombinant FVIIa; D015942:Factor VIIa