Statistical Analysis Plan for the INTEnsive care bundle with blood pressure Reduction in Acute Cerebral haemorrhage Trial (INTERACT3)

INTERACT3 aims to determine the effectiveness of a goal-directed care bundle of intensive blood pressure (BP) lowering, glycemic control, antipyrexia, and anticoagulation reversal treatment, compared to usual standard of care, in patients with acute intracerebral hemorrhage (ICH). It is designed as an nternational, multicenter, stepped-wedge (4 phases/3 steps) cluster randomized trial. This statistical analysis plan (SAP) pre-specifies the method of analysis for every outcome and key variable collected in the trial. The primary analysis will consist in an ordinal logistic regression adjusted for the stepped-wedge design. The SAP also includes planned sensitivity analyses including covariate adjustments, missing data imputations and subgroup analyses.