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Effect of recombinant activated coagulation factor VII on hemorrhage expansion among patients with spot sign–positive acute intracerebral hemorrhage: The SPOTLIGHT and STOP-IT randomized clinical trials

JAMA Neurology Aug 26, 2019

Gladstone DJ, Aviv RI, Demchuk AM, et al. - Researchers assessed if hemorrhage expansion could be lowered among patients presenting to the emergency department with an acute intracerebral hemorrhage (ICH) and a spot sign on computed tomography angiography, a marker of hemorrhage expansion, using recombinant activated coagulation factor VII (rFVIIa). From randomized clinical trials targeting patients with spot sign–positive ICH, data of 69 patients were pooled for analysis. As soon as possible within 6.5 hours of stroke onset, random assignment of eligible patients to either 80 μg/kg of intravenous rFVIIa or placebo was done. Outcomes revealed no significant reduction in hemorrhage expansion when rFVIIa was administered up to 6.5 hours from stroke onset, although nearly all patients received the treatment more than 2 hours after stroke onset. Data thereby do not support rFVIIa as clinically valuable for patients with spot sign–positive ICH.

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