title: The effect of activated factor VII for intracerebral hemorrhage beyond 3 hours versus within 3 hours.
abstract: OBJECTIVE
  Recombinant-activated factor VII (rFVIIa) is an investigational treatment for intracerebral hemorrhage (ICH). We have evaluated the drug's treatment effect based on time to treatment.
  
  
  METHODS
  ICH patients treated up to 4 hours from symptom onset were divided based on time to treatment: <or=3 hours (3H) and 3 to 4 hours (4H). Head CT was done at baseline and 24 hours. Outcome measures included: ICH growth at 24 hours, mortality, favorable outcome and discharge disposition. A cohort of nontreated matched ICH patients was used to asses the clinical efficacy.
  
  
  RESULTS
  Forty-six patients were treated with rFVIIa: 24 in the 3H group (range 70 to 180 minutes), 22 in the 4H group (range 181 to 300). One hundred and forty-eight patients formed the control group. Mean baseline ICH volume was 8.8 mL for 3H and 10.1 mL for 4H. Mean 24-hour volume was 9.3 mL for 3H (absolute increase 1.05 mL, relative increase 11.9%) and 11.5 mL for 4H (absolute increase 1.1 mL, relative increase 10.9%); P=0.47 is for the difference in relative increase. Mortality was 12.5% for 3H group, 13.6% for 4H, and 13.1% for the control. In the 3H group, 58.3% were discharged with a poor outcome, compared with 54.5% in 4H and 54.1% in the control. Thrombotic adverse events occurred in 11.1% of patients treated with rFVIIa.
  
  
  CONCLUSIONS
  In our off-label with rFVIIa, we did not find evidence of a treatment effect based on time to treatment. Other criteria should be sought to identify patients who might benefit clinically from rFVIIa.
authors.forename: Hen
authors.initials: H
authors.lastname: Hallevi
authors.forename: Nicole R
authors.initials: NR
authors.lastname: Gonzales
authors.forename: Andrew D
authors.initials: AD
authors.lastname: Barreto
authors.forename: Sheryl
authors.initials: S
authors.lastname: Martin-Schild
authors.forename: Karen C
authors.initials: KC
authors.lastname: Albright
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Noser
authors.forename: Kachi
authors.initials: K
authors.lastname: Illoh
authors.forename: Aslam M
authors.initials: AM
authors.lastname: Khaja
authors.forename: Teresa
authors.initials: T
authors.lastname: Allison
authors.forename: Miguel A
authors.initials: MA
authors.lastname: Escobar
authors.forename: Hashem M
authors.initials: HM
authors.lastname: Shaltoni
authors.forename: James C
authors.initials: JC
authors.lastname: Grotta
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002543:Cerebral Hemorrhage / Q000097:blood* / Q000188:drug therapy* / Q000401:mortality; D015331:Cohort Studies; D015942:Factor VIIa / Q000008:administration & dosage* / Q000009:adverse effects; D006406:Hematoma / Q000097:blood / Q000188:drug therapy / Q000401:mortality; D006801:Humans; D008875:Middle Aged; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015942:Factor VIIa