International Care Bundle Evaluation in Cerebral Hemorrhage Research (I-CATCHER): Study protocol for a multicenter, batched, parallel, cluster-randomized trial with a baseline period

RATIONALE: A care bundle approach to the management of spontaneous intracerebral hemorrhage (ICH) has been shown to benefit patients in low- and middle-income countries (LMIC), but uncertainty persists over the specific components and its applicability in high-income countries (HICs). AIMS: An international collaborative initiative aimed at determining whether implementation of a care bundle improves functional outcome for patients with ICH in HIC. METHODS: An international, multicenter, batched, parallel, cluster-randomized clinical trial focused on implementation and quality improvement for adults with spontaneous ICH ⩽ 24 h of symptom onset. The care bundle includes time- and target-based interventions: early intensive blood pressure lowering, hyperglycemia and pyrexia management, anticoagulation reversal, avoidance of do-not-resuscitate orders, repeat imaging, and referral pathways for intensive care and neurosurgery. An embedded process evaluation will assess the effectiveness and implementation of the care bundle. SAMPLE SIZE: A total of 110 hospitals with 3500 ICH participants is estimated to provide 90% power (α = 0.05) to detect a plausible treatment effect of 0.20 improvement in utility-weighted modified Rankin scale (UW-mRS) scores. OUTCOMES: The primary outcome is UW-mRS at 6 months. Secondary outcomes include death, functional status, and health-related quality of life. Implementation outcomes include adoption, fidelity, acceptability, sustainability, and integration. DISCUSSION: We aim to provide reliable evidence to accelerate practice change for integration of a multifaceted ICH care bundle as a critical component of acute stroke care worldwide. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT06429332.