Intracerebral hemorrhage (ICH) comprises 15% of all
strokes, and carries the highest risk of mortality and poor long-term outcome. ICH has long been recognized as the least treatable form of
stroke, and
hematoma volume as the strongest single predictor of mortality and outcome. CT-based studies have found that early substantial
hematoma expansion occurs in 18-38% of patients initially scanned within 3 h of symptom onset. This finding is associated with early neurological deterioration and an increased risk of poor outcome. Ultra-early
hemostatic therapy might be beneficial in preventing
hematoma growth, resulting in improved mortality and neurological function. Recombinant
activated factor VII (
rFVIIa) promotes local hemostasis in the presence or absence of coagulopathy at sites of
vascular injury, and is a promising treatment for arresting active
bleeding in ICH. The safety and feasibility of this approach was confirmed in a phase IIb randomized, double-blind, placebo-controlled, dose-ranging trial of 399 patients with non-coagulopathic ICH. Administration of
rFVIIa within 4 h of ICH onset resulted in a significant reduction of
hematoma expansion at 24 h, and reduced mortality and improved functional outcome at 90 days. A confirmatory phase III trial (The FAST Trial) to confirm these results will complete enrollment in the end of 2006.