title: Potential applicability of recombinant factor VIIa for intracerebral hemorrhage.
abstract: OBJECTIVE
  To date, there are no proven, effective treatments for intracerebral hemorrhage (ICH) beyond supportive medical care. A recent randomized, blinded, placebo-controlled trial of recombinant factor VIIa (rFVIIa) administered intravenously within 4 hours of ICH onset reported a reduction in morbidity and mortality compared with placebo. We sought to determine the potential applicability of rFVIIa in a large, population-based cohort of ICH patients.
  
  
  METHODS
  All of the patients age > or =18 years hospitalized with nontraumatic ICH in the Greater Cincinnati region were identified from May 1998 to July 2001 and August 2002 to April 2003. Patient demographics were compared with the inclusion and exclusion criteria from the rFVIIa trial to determine eligibility for treatment and reasons for exclusion. Mortality in the eligible patient group was compared with the placebo group in the rFVIIa trial.
  
  
  RESULTS
  Over 4 calendar years, 1018 ICH patients were identified; of these, 133 (13.1%) had no exclusions and presented within the prescribed time window. An additional 45 patients (4.4%) may have been eligible but had uncertain onset or computed tomography scan times. The most common reasons for exclusion (not mutually exclusive) were late presentation (n=398), vaso-occlusive disease (n=369), deep coma (n=219), and prolonged international normalized ratio or partial thromboplastin time (n=200). Mortality at 90 days among potentially eligible patients was the same as for the placebo group in the rFVIIa trial (29% versus 29%; P=0.99).
  
  
  CONCLUSIONS
  In this large, population-based ICH cohort, 13.1% to 17.5% of patients would have qualified for treatment with rFVIIa by trial criteria.
authors.affiliation: Department of Neurology, University of Cincinnati Medical Center, Cincinnati, OH 45267-0525, USA. matthew.flaherty@uc.edu
authors.forename: Matthew L
authors.initials: ML
authors.lastname: Flaherty
authors.forename: Daniel
authors.initials: D
authors.lastname: Woo
authors.forename: Mary
authors.initials: M
authors.lastname: Haverbusch
authors.forename: Charles J
authors.initials: CJ
authors.lastname: Moomaw
authors.forename: Padmini
authors.initials: P
authors.lastname: Sekar
authors.forename: Laura
authors.initials: L
authors.lastname: Sauerbeck
authors.forename: Brett
authors.initials: B
authors.lastname: Kissela
authors.forename: Dawn
authors.initials: D
authors.lastname: Kleindorfer
authors.forename: Joseph P
authors.initials: JP
authors.lastname: Broderick
mesh_terms: D000368:Aged; D002543:Cerebral Hemorrhage / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000401:mortality*; D015942:Factor VIIa / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007629:Kentucky / Q000453:epidemiology; D008297:Male; D009820:Ohio / Q000453:epidemiology; D011994:Recombinant Proteins / Q000627:therapeutic use; D012189:Retrospective Studies; D015996:Survival Rate; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
chemical_list: D011994:Recombinant Proteins; D015942:Factor VIIa