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.