Potential applicability of recombinant factor VIIa for intracerebral hemorrhage.
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.
Flaherty
Matthew L
ML
Department of Neurology, University of Cincinnati Medical Center, Cincinnati, OH 45267-0525, USA. matthew.flaherty@uc.edu
Woo
Daniel
D
Haverbusch
Mary
M
Moomaw
Charles J
CJ
Sekar
Padmini
P
Sauerbeck
Laura
L
Kissela
Brett
B
Kleindorfer
Dawn
D
Broderick
Joseph P
JP
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
D011994:Recombinant Proteins; D015942:Factor VIIa