Recombinant Activated Factor VII for Acute Intracerebral Hemorrhage

Recombinant Activated Factor VII for Acute Intracerebral Hemorrhage

February 2007 Part II | Stephan A. Mayer, MD, FCCM
Intracerebral hemorrhage (ICH) is the least treatable form of stroke, with a high mortality rate and significant hematoma growth in many patients. Recombinant activated factor VII (rFVIIa) is a potent hemostatic agent initially developed for treating bleeding in hemophilia patients. A phase IB randomized, double-blind, placebo-controlled trial evaluated rFVIIa in 399 ICH patients to determine its efficacy in limiting ongoing bleeding and improving outcomes. The study found that all three doses tested (40, 80, and 160 μg/kg) significantly reduced hematoma growth by approximately 5 milliliters on average. Notably, rFVIIa was associated with a 38% relative reduction in mortality and improved functional outcomes among survivors, despite a 5% frequency of arterial thromboembolic events. A large phase III trial (FAST trial) is currently underway to confirm these findings. The potential role of rFVIIa in treating coagulopathic ICH is also discussed, highlighting its rapid normalization of international normalized ratio (INR) in anticoagulated patients. Further research is needed to optimize dosing and assess safety in this high-risk population.Intracerebral hemorrhage (ICH) is the least treatable form of stroke, with a high mortality rate and significant hematoma growth in many patients. Recombinant activated factor VII (rFVIIa) is a potent hemostatic agent initially developed for treating bleeding in hemophilia patients. A phase IB randomized, double-blind, placebo-controlled trial evaluated rFVIIa in 399 ICH patients to determine its efficacy in limiting ongoing bleeding and improving outcomes. The study found that all three doses tested (40, 80, and 160 μg/kg) significantly reduced hematoma growth by approximately 5 milliliters on average. Notably, rFVIIa was associated with a 38% relative reduction in mortality and improved functional outcomes among survivors, despite a 5% frequency of arterial thromboembolic events. A large phase III trial (FAST trial) is currently underway to confirm these findings. The potential role of rFVIIa in treating coagulopathic ICH is also discussed, highlighting its rapid normalization of international normalized ratio (INR) in anticoagulated patients. Further research is needed to optimize dosing and assess safety in this high-risk population.
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