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.

BACKGROUND

Although spontaneous intracerebral hemorrhage (sICH) accounts for only 10-15% of all strokes, it remains the deadliest subtype. We aimed to evaluate the efficacy and safety of recombinant activated factor VII (rFVIIa) in sICH.

METHODS

We systematically searched four electronic databases through February 28, 2026, for randomized clinical trials (RCTs) comparing rFVIIa with placebo in sICH. Risk ratios (RRs) and mean differences (MDs) with 95% confidence intervals (CIs) were utilized for dichotomous and continuous outcomes, respectively. The primary efficacy outcomes were good functional outcome (modified Rankin Scale [mRS] 0-2) and poor functional outcome (mRS 4-6) at 90 days.

RESULTS

Seven RCTs, comprising 2,022 patients, were included. Compared with placebo, rFVIIa was not associated with a significant improvement in good functional outcome at 90 days (RR: 1.13, 95% CI: 0.92 to 1.38, p = 0.25) or a significant reduction in intracerebral hemorrhage volume at 24 h (MD: -1.61, 95% CI: -4.42 to 1.19, p = 0.26). Furthermore, rFVIIa was associated with a numerically higher incidence of safety events; however, this difference did not reach statistical significance.

CONCLUSION

In unselected patients with sICH, rFVIIa does not provide a clinically meaningful functional benefit, and the overall evidence supports a recommendation against its routine use.