Stroke is a major health problem worldwide, causing high morbidity and mortality.
Intracerebral hemorrhage (ICH) accounts for 15% of
stroke cases in the US and Europe and up to 30% in Asian populations. It is less treatable than other forms of
stroke and causes higher morbidity and disability. Data suggest that early hematomy growth is the principal cause of early neurological deterioration after ICH. Prospective and retrospective studies indicate that early
hematoma growth occurs in 18-38% of patients scanned within 3 h of ICH onset, and that
hematoma volume is an important predictor of 30-day mortality. As
hematoma growth in acute ICH is a dynamic process, intervention with ultra-early
hemostatic therapy could lead to minimization and even prevention of early hematomy growth. Recombinant
activated factor VII (
rFVIIa, '
NovoSeven'), a powerful initiator of hemostasis, is approved for the treatment of
bleeding in patients with
hemophilia and inhibitors and may also promote hemostasis in patients with normal coagulation. rFVa acts locally at the
bleeding site without activating systemic coagulation and may be a valuable
therapy during the hyperacute stage of ICH. A randomized, double-blind, placebo-controlled, dose-ranging trial is currently in progress to investigate the potential of
rFVIIa as an ultra-early
hemostatic therapy to prevent or minimize
hematoma growth in ICH patients without coagulopathy.