Efficacy and safety of recombinant activated factor VII for spontaneous intracerebral Hemorrhage: a GRADE-assessed meta-analysis of randomized controlled trials using frequentist and Bayesian approaches.
Mohammed A Elbahloul, Aliaa Gamal, Mayer H Ghaly et al.
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In 30 seconds
This GRADE-assessed meta-analysis of seven randomized controlled trials compared recombinant activated factor VII (rFVIIa) with placebo in 2,022 patients with spontaneous intracerebral hemorrhage. At 90 days, rFVIIa was not associated with a significant improvement in good functional outcome (modified Rankin Scale 0–2): RR 1.13, 95% CI 0.92 to 1.38, p = 0.25. It also did not significantly reduce hematoma volume at 24 hours. Safety events were numerically more frequent with rFVIIa, but the difference was not statistically significant.
Key findings
- Good functional outcome at 90 days did not significantly differ with rFVIIa versus placebo (RR: 1.13, 95% CI: 0.92 to 1.38, p = 0.25).
- The 24-hour change in intracerebral hemorrhage volume was not significantly different (MD: -1.61, 95% CI: -4.42 to 1.19, p = 0.26).
- Safety events were numerically more frequent with rFVIIa, but the difference was not statistically significant.
Why it matters
The pooled randomized evidence does not show a functional benefit or significant reduction in hemorrhage volume for rFVIIa in unselected patients with spontaneous intracerebral hemorrhage. The numerically higher incidence of safety events also warrants consideration, although the reported difference was not statistically significant. These findings help frame the balance of potential benefit and harm when evaluating this intervention.
What to keep in mind
The meta-analysis is limited to the randomized trials identified through February 28, 2026; the abstract does not report further limitations.