Hematoma expansion shift analysis to assess acute intracerebral hemorrhage treatments

Objective: Hematoma expansion (HE) is commonly analyzed as a dichotomous outcome in intracerebral hemorrhage (ICH) trials.  In this proof-of-concept study, we propose a “HE shift” analysis model as a method to improve the evaluation of candidate ICH therapies.

Methods: Using data from the Antihypertensive Treatment of Acute Cerebral Hemorrhage II (ATACH-2) trial, we performed HE shift analysis in response to intensive blood pressure lowering by generating polychotomous strata based on a) previously established HE definitions, b) percentile/absolute quartiles of hematoma volume change, and c) quartiles of 24-hour follow-up hematoma volumes. The relationship between blood pressure treatment and HE shift was explored using proportional odds models.

Results: The primary analysis population included 863 patients. In both treatment groups, approximately one-third of patients exhibited no HE. Using a trichotomous HE stratification, the highest strata of ≥33% revealed a 5.8% reduction in ...