This was recently illustrated in a Phase II clinical trial in ALI/ARDS patients where administration of the TF-FVIIa complex inhibitor, active site inactivated FVIIa (FVIIai), resulted in a dose-depended increase in major bleeding events (3.8% for the low dose to 17% for the highest dose) and an increased 28-day mortality rate [15]. This evidence concerns the gene TF and acute respiratory distress syndrome.