Recombinant factor VIIa for spontaneous intracerebral haemorrhage: a meta-analysis of randomised controlled trials

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Abstract

BACKGROUND: Early haematoma expansion is a key determinant of outcome in spontaneous intracerebral haemorrhage (sICH) and a biologically plausible therapeutic target. Recombinant activated factor VII (rFVIIa) has demonstrated haemostatic effects in randomised controlled trials (RCTs) but its impact on functional outcome remains uncertain. METHODS: We performed a systematic review and meta-analysis of RCTs evaluating rFVIIa in adults with sICH. MEDLINE, Embase and CENTRAL were searched from inception to March 2026. Random effects models pooled radiographic, clinical and safety outcomes. Primary outcomes were 24-hour ICH volume, severe disability (modified Rankin Scale 4-6) and all-cause mortality at 90 days. Risk of bias was assessed using the Cochrane Risk of Bias 2 (RoB 2) tool and certainty of evidence using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) framework. RESULTS: Six trials including 2083 patients were analysed. rFVIIa significantly reduced 24-hour ICH volume (mean difference -2.93 mL; 95% CI -4.75 to -1.12; p=0.002; I2=0.0%). There was no significant reduction in severe disability (risk ratio (RR) 0.92; 95% CI 0.84 to 1.01; p=0.08; I2=13.0%) or mortality (RR 0.86; 95% CI 0.71 to 1.04; p=0.12; I2=0.0%). Secondary functional outcomes showed modest and non-robust signals. No significant differences were observed in thromboembolic complications, although event rates were low. Certainty of evidence was moderate. CONCLUSIONS: rFVIIa consistently reduces early haematoma volume in sICH but does not clearly improve functional outcome or survival. These findings highlight a persistent dissociation between biological efficacy and clinical benefit. Future progress will depend on aligning ultra-early treatment, patient selection and disease biology to identify the subgroup in whom haemostatic therapy can meaningfully alter outcome. PROSPERO REGISTRATION NUMBER: CRD420261346211.

Abstract as published, via PubMed.