Advancing the Surgical Treatment of Intracerebral Hemorrhage: Study Design and Research Directions

Abstract

In this narrative review, we discuss aspects of study design for research in the surgical treatment of patients with spontaneous acute intracerebral hemorrhage (ICH). We emphasize the importance of carefully defining the primary end point relevant to the intervention under investigation, whether this is technical (i.e., residual hematoma volume) or clinical (i.e., mortality or functional outcome), and the timing of its assessment. Compared with patients with acute ischemic stroke, patients with spontaneous acute ICH may take longer to fully recover. Efficient patient recruitment is essential for all research studies and deferred consent is an option to allow disabled and critically ill patients to be included. Although central concealment of the randomization process, often with a method of stratification to ensure that prognostic variables are balanced between groups, it is often appropriate to undertake analysis of the treatment effect adjusted for various predefined covariables. The definition of minimally invasive surgery, and its use and timing in relation to ICH, requires urgent assessment. Future studies could be better designed and executed as part of a large (inter)national ICH trials consortium, consisting of dedicated interdisciplinary teams of neurologists, neurosurgeons, intensivists, and epidemiologists. We advocate studies to be pragmatic and adhere to the IDEAL recommendations and CONSORT guidelines.

Keywords: Clinical trials; Consent; Intracerebral hemorrhage; Outcome; Protocol; Study design; Surgery.