The Spot Sign for predicting and treating ICH growth study (STOP-IT) is a phase II study that seeks to determine whether patients who suffer an intracranial hemorrhage (ICH) and show contrast extravasation on CT angiography (CTA) can benefit from a coagulation factor treatment with recombinant Factor Vila (rFVIIa). In an unselected population of patients with ICH preliminary data showed that contrast extravasation during CTA (spot sign) predicts hematoma expansion and poorer neurological outcome. Patients with signs of ongoing ICH expansion may be more likely to benefit from rFVIIa treatment. In the STOP-IT study adult patients who present within 6 hours of an acute ICH will receive a head CT and CTA. Patients who show the spot sign, which is contrast extravasation into the hematoma seen on CTA will be randomized to receive 80ug/kg fFVIIa or placebo. We plan to contribute 30 patients in San Diego to a total of 364 patients study-wide over 5 years. The study will show if the spot sign can be identified reliably, if the spot sign correlates with outcome and if patients with a positive spot the spot sign benefit from treatment with rFVIIa. The primary outcome is measured as the percent of patients in each treatment group with hematoma that growth from baseline to the 24 hours CT scan.. This trial fits well with the other projects proposed by UCSD SPOTRIAS since there is no overlap with other trials, and the stroke team (see Core C) will be called in for intracerebral hemorrhages due to Code Stroke activation prior to a CT head scan.
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