An Investigator Initiated and Conducted, International, Multicenter, Stepped Wedge Cluster Randomized Study of a Care Bundle of Physiological Control Strategies in Acute Intracerebral Hemorrhage

Objectives: To determine the effectiveness of a goal-directed care bundle of active management involving early physiological control (intensive blood pressure [BP] lowering, glycemic control, early treatment of pyrexia, and rapid reversal of anticoagulation), versus usual standard of care, on functional outcome (defined by a shift in scores on the modified Rankin scale [mRS] in patients with acute spontaneous intracerebral hemorrhage (ICH).

Study design: An international, multicentre, stepped wedge, cluster randomized clinical trial design involves implementation of a guideline-recommended intervention package applied to patients with ICH as part of routine care. Patients are only excluded if they refuse to have details of their management included and/or participate in the follow-up procedures.

Study site inclusion criteria: Organized systems of acute stroke care; no established comprehensive protocols for the management of patients with ICH; suitable location, infrastructure and willingness to participate in clinical research; large volume of ICH patients (approx. 100 per year). The hospitals will have training, prior to their activation and commencement of the intervention. Data collection at baseline,Day 1, discharge/ Day 7, and 6-month (end of follow-up), will be captured through a web database. Randomized allocation of intervention will be assigned by a statistician not otherwise involved in the study according to a statistical program stratified by the country of the site.

Process Evaluation: Mixed methods were used to explore how the care bundle, a complex intervention, is implemented, as well as to understand clinicians' perspectives, a prospective process evaluation will be conducted alongside the trial implementation. Intervention fidelity, reach, dose, adaption, feasibility and appropriateness of the goal-directed care bundle will be evaluated within the trial.

Economic Evaluation: A multi-country within-trial economic evaluation will be conducted, from each healthcare system's perspective. Healthcare utilisation costs incurred within the initial hospital visit will be estimated using administratively collected hospital records.