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脑出血幸存者的重复评估:一项多中心前瞻性观察性研究的方案

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

作者信息

Ziai Wendy, Woo Daniel, Sansing Lauren, Hanley Daniel, Ostapkovich Noeleen, Triene Kevin, Gilkerson Lee A, Thompson Richard, Walborn Nathan, Lane Karen, McBee Nichol, Langefeld Carl D, Howard Timothy David, Vagal Achala, Flaherty Matthew L

机构信息

Division of Neurocritical Care, Department of Neurology and Neurosurgery, Johns Hopkins University, Baltimore, Maryland, USA

Division of Brain Injury Outcomes, Department of Neurology and Neurosurgery, Johns Hopkins University, Baltimore, Maryland, USA.

出版信息

BMJ Open. 2025 Feb 6;15(2):e094322. doi: 10.1136/bmjopen-2024-094322.

Abstract

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.

摘要

背景

幸存者重复评估(REASSESS)研究将进行长期认知、功能和神经精神表现评估,以确定自发性脑出血(ICH)的引流是否能降低老年大脑后期认知衰退的风险。

方法与分析

本研究将比较两种ICH治疗策略下的认知衰退率。第一种策略是采用微创手术(MIS),其技术与以下三项研究相似:(1)脑出血微创引流加rt-PA治疗三期(MISTIE III)试验;(2)早期微创清除脑出血(ENRICH)试验;(3)一组连续接受MIS治疗的单中心患者队列。第二种策略是目前的非手术标准治疗,使用MISTIE III和ENRICH中对照组的数据,以及脑出血的种族/民族差异(ERICH)研究扩展至ERICH纵向研究中的对比数据,该研究对900多例ERICH病例进行了系列认知检查。如果成功,REASSESS研究可以证明减少ICH体积是降低进行性认知衰退风险的关键目标,确定残余血肿体积减少的目标,并确定更大的残余血肿体积是否会导致长期炎症状态。

伦理与传播

本研究已获得约翰霍普金斯大学机构审查委员会(IRB00311985)的批准。研究结果将发表在学术同行评审期刊上。

试验注册号

NCT05611918;ClinicalTrials.gov;于2023年5月23日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e553/11800296/2220297f0dae/bmjopen-15-2-g001.jpg

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