Background: An early intensive care bundle improved intracerebral hemorrhage (ICH) outcomes in low-resource settings, but its effectiveness across diverse healthcare systems remains uncertain.
Aims: To determine if a structured, evidence-based Care Bundle for rapid physiological stabilization and standardized referral improves functional recovery after ICH.
Methods: This international, multicenter, batched, parallel cluster-randomized trial features an embedded implementation framework. Hospitals are randomized to usual care or a Care Bundle targeting rapid control of blood pressure (BP), glucose, and temperature; anticoagulation reversal; standardized specialist referrals; and avoidance of early treatment limitations. The primary outcome is the 6-month utility-weighted modified Rankin Scale (UW-mRS). Secondary outcomes include mortality, health-related quality of life, and implementation outcomes (e.g. fidelity, feasibility, sustainability). Target enrollment is 3,500 adults (≤24 hours of spontaneous ICH) across 110 hospitals, providing 90% power to detect an effect size of 0.20.
Results: Currently, 49 sites across eight countries/regions are active, with 1,000 participants enrolled as of March 2026 from Sweden, Iceland, Canada, Italy, Australia, Malaysia, the US, and Hong Kong. Preliminary baseline usual-care data reveal suboptimal adherence to acute ICH targets: only 13% achieved BP targets within 30 minutes, 58% received anticoagulant reversal within 1 hour, 30% of anticoagulated patients received a repeat CT within 24 hours, and 27% faced early care limitations within 48 hours.
Conclusion: Suboptimal adherence to established acute ICH management targets during routine care underscores the necessity of this pragmatic effectiveness and implementation trial across diverse healthcare settings.