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.