ABSTRACT NUMBER: ESOC2026OT98 I-CATCHER: AN INTERNATIONAL, BATCHED, CLUSTER-RANDOMIZED, STEPPED-WEDGE TRIAL OF CARE BUNDLE IMPLEMENTATION FOR ACUTE INTRACEREBRAL HEMORRHAGE

Abstract Background and aims A Care Bundle involving early intensive blood pressure (BP) lowering improved outcome after acute spontaneous intracerebral hemorrhage (ICH) in low-resource settings. However, uncertainty remains regarding the effectiveness across diverse healthcare systems. Methods To determine whether implementation of a comprehensive, structured, evidence-based Care Bundle targeting rapid physiological stabilization and standardized referral pathways improves functional recovery after ICH. Results An international, multicenter, batched, parallel, cluster-randomized trial with an embedded implementation framework. Adults ≤24 hours of ICH receive either: a Care Bundle comprising time- and target-based management of BP, glucose, temperature; anticoagulation reversal; avoidance of early treatment limitations; and standardized pathways for intensive care and neurosurgical referral; or usual care. Hospitals are randomized in batches across 3 phases: baseline, randomized evaluation, and post-implementation. A total of 3,500 patients at 110 hospitals is estimated to provide 90% power (α=0.05) to detect a UW-mRS effect size of 0.20. Conclusions Outcomes include utility-weighted modified Rankin scale (UW-mRS, primary), mortality, 6-month health-related quality of life, and implementation outcomes (e.g. fidelity, feasibility, sustainability). Conflict of interest