Ultra-early hemostatic therapy for primary intracerebral hemorrhage: a review.

Stroke is a major health problem worldwide, causing high morbidity and mortality. Intracerebral hemorrhage (ICH) accounts for 10% of stroke cases in the United States and Europe and up to 30% in Asian populations. Intracerebral hemorrhage is less treatable than other forms of stroke and causes higher morbidity and disability. Data suggest that early hematoma 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 three hours of ICH onset, and that hematoma volume is an important predictor of 30-day mortality. 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 can also promote hemostasis in patients with normal coagulation. A Phase-IIB randomized, double-blind, placebo-controlled, dose-ranging trial has been conducted in 399 patients with ICH to investigate the potential of rFVIIa as an ultra-early hemostatic therapy. A reduction in hematoma growth in non-coagulopathic ICH patients was evident with reduced mortality and improved clinical outcome at three months. The significance of these findings for neurocritical care is discussed.