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The REpeated ASSEssment of SurvivorS in intracerebral haemorrhage: protocol for a multicentre, prospective observational study

Published 3 months ago2 minute read

Background: The REpeated ASSEssment of SurvivorS (REASSESS) study will conduct long-term cognitive, functional and neuropsychiatric performance assessments to determine whether evacuation of spontaneous intracerebral haemorrhage (ICH) reduces the risk of later cognitive decline in the ageing brain.

Methods and analysis: This study will compare rates of cognitive decline under two treatment strategies for ICH. The first strategy is the use of minimally invasive surgery (MIS) with similar techniques as performed in (1) the Minimally Invasive Surgery plus rt-PA in the Treatment of Intracerebral haemorrhage Evacuation phase III (MISTIE III) trial, (2) the Early MiNimally-invasive Removal of IntraCerebral Haemorrhage (ENRICH) trial and (3) a single-centre cohort of consecutively treated patients with MIS. The second strategy is the current non-surgical standard of care using data from controls in MISTIE III and ENRICH and comparative data from The Ethnic/Racial Variations of ICH (ERICH) studyextended into the ERICH-Longitudinal study, which followed over 900 of ERICH cases with serial cognitive examinations. If successful, the REASSESS study could demonstrate that reduction of ICH volume is a critical target to reduce the risk of progressive cognitive decline, establish targets for residual haematoma volume reduction and determine if greater residual haematoma volume leads to a long-term inflammatory state.

Ethics and dissemination: Approval of this study was obtained from the Johns Hopkins University Institutional Review Board (IRB00311985). The findings of the study will be published in academic peer-reviewed journals.

Trial registration number: NCT05611918; ClinicalTrials.gov; registered on 23 May 2023.

Keywords: Dementia; Intracerebral Hemorrhage; NEUROSURGERY; Observational Study; Stroke.

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Competing interests: All authors have completed the ICMJE uniform disclosure form at http://www.icmje.org/disclosure-of-interest/ and declare: WZ, DW, LHS, DFH, CDL, TDH, AV and MLF receive funding from the National Institutes of Health. WZ is an associate editor for the journal Neurocritical Care. DFH reports grants from the Department of Defense, and personal fees from Neurotrope, Neurelis, medico-legal consulting, outside the submitted work. AV is a consultant for Cerebra AI and GE Healthcare. All authors have no financial relationships with any organisations that might have an interest in the submitted work in the previous 3 years; no other relationships or activities that could appear to have influenced the submitted work.

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