A Cochrane review included 5 phase II and one phase III RCTs with 1398 patients with acute intracerebral haemorrhage (ICH). They were randomized to treatment within 4 hours of ICH onset: 423 participants received placebo and 975 participants received haemostatic drugs (973 received recombinant activated factor VII (rFVIIa) and 2 received epsilon-aminocaproic acid (EACA)). rFVIIa did not significantly reduce 90-day mortality after ICH (risk ratio (RR) 0.85, 95% CI 0.58 to 1.25) or death or dependence on the modified Rankin Scale (grades 4 to 6) within 90 days of ICH (RR 0.91, 95% CI 0.72 to 1.15). There was a trend towards more participants on rFVIIa experiencing thromboembolic serious adverse events (RR 1.37, 95% CI 0.74 to 2.55).
Comment: The quality of evidence is downgraded by study quality (unclear allocation concealment) and indirectness (the studied patients were younger, had smaller ICH volumes, and were more likely to be conscious at enrolment than normal ICH patients)