Hemostatic agents in the treatment of non-coagulopathic intraparenchymal hemorrhage

Activated Factor VII
There is no evidence that activated factor VIIa is effective for treatment of intraparenchymal hemorrhage (IPH). While it may prevent hemorrhagic growth, its thromboembolic complications likely limit its effects. Studies have been unable to successfully identify a population who may benefit from this therapy, and its use in IPH, if any, remains unclear.

Initial trials
Two trials were done in patients with IPH and showed a consistent reduction in hematoma volume, but the larger trial showed no benefit for function outcome or mortality and a higher incidence of thromboembolic events.

Recombinant Activated Factor VII Intracerebral Hemorrhage Trial (2005)
This trial included 399 patients with intraparenchymal hemorrhage randomized to recombinant activated factor VII (rFVIIa) versus placebo. Treatment with rFVII within 4 hours reduced hematoma growth, reduced 90-day mortality (18% vs 29%), and improved functional outcome at 90 days.

Factor Seven for Acute Hemorrhagic Stroke (FAST) Trial (2008)
This trial randomized 841 patients with IPH to rFVIIa versus placebo. They showed a reduction in hematoma growth but no difference in functional outcome or mortality, and a higher incidence of thromboembolic events.

New trials in patients selected for active bleeding using CTA spot sign
With no benefit seen in the FAST trial, one hypothesis was that rFVIIa would be of benefit in a population at high risk of bleeding. The CTA spot sign had some evidence that it predicted hemorrhagic expansion, so trials began to look at using it to select high-risk patients who may benefit from hemostatic agents.

"Spot Sign" Selection of Intracerebral Hemorrhage to Guide Hemostatic Therapy (SPOTLIGHT) and Spot Sign for Predicting and Treating ICH Growth Study (STOP-IT)
These two trials were published together and included collectively only 69 patients despite enrolling attempts from 2010-2016. They randomized patients with spot-sign positive IPH to either rFVIIa or placebo within 6.5 hours of onset and found no difference in hemorrhage growth or mortality.