The REpeated ASSEssment of SurvivorS in intracerebral haemorrhage: protocol for a multicentre, prospective observational study
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.Me...
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BMJ Publishing Group
2025-02-01
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| Online Access: | https://bmjopen.bmj.com/content/15/2/e094322.full |
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| author | Daniel Woo Richard Thompson Carl D Langefeld Nichol McBee Daniel Hanley Matthew L Flaherty Lauren Sansing Karen Lane Lee A Gilkerson Achala Vagal Nathan Walborn Wendy Ziai Noeleen Ostapkovich Kevin Triene Timothy David Howard |
| author_facet | Daniel Woo Richard Thompson Carl D Langefeld Nichol McBee Daniel Hanley Matthew L Flaherty Lauren Sansing Karen Lane Lee A Gilkerson Achala Vagal Nathan Walborn Wendy Ziai Noeleen Ostapkovich Kevin Triene Timothy David Howard |
| author_sort | Daniel Woo |
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| description | 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. |
| format | Article |
| id | doaj-art-da5520b2c24e4c61a0bb9276bd1a3be1 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-da5520b2c24e4c61a0bb9276bd1a3be12025-02-07T03:35:13ZengBMJ Publishing GroupBMJ Open2044-60552025-02-0115210.1136/bmjopen-2024-094322The REpeated ASSEssment of SurvivorS in intracerebral haemorrhage: protocol for a multicentre, prospective observational studyDaniel Woo0Richard Thompson1Carl D Langefeld2Nichol McBee3Daniel Hanley4Matthew L Flaherty5Lauren Sansing6Karen Lane7Lee A Gilkerson8Achala Vagal9Nathan Walborn10Wendy Ziai11Noeleen Ostapkovich12Kevin Triene13Timothy David Howard143 Department of Neurology and Rehabilitation Medicine, University of Cincinnati, Cincinnati, Ohio, USA6 Department of Biostatistics, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA7 Department of Biostatistics and Data Science (CDL), Biochemistry (TDH) and the Center for Precision Medicine, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA2 Division of Brain Injury Outcomes, Department of Neurology and Neurosurgery, Johns Hopkins University, Baltimore, Maryland, USA2 Division of Brain Injury Outcomes, Department of Neurology and Neurosurgery, Johns Hopkins University, Baltimore, Maryland, USA5 Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA4 Department of Neurology, Yale University School of Medicine, New Haven, Connecticut, USA2 Division of Brain Injury Outcomes, Department of Neurology and Neurosurgery, Johns Hopkins University, Baltimore, Maryland, USA5 Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA8 Department of Radiology, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA2 Division of Brain Injury Outcomes, Department of Neurology and Neurosurgery, Johns Hopkins University, Baltimore, Maryland, USA1 Division of Neurocritical Care, Department of Neurology and Neurosurgery, Johns Hopkins University, Baltimore, Maryland, USA2 Division of Brain Injury Outcomes, Department of Neurology and Neurosurgery, Johns Hopkins University, Baltimore, Maryland, USA2 Division of Brain Injury Outcomes, Department of Neurology and Neurosurgery, Johns Hopkins University, Baltimore, Maryland, USA7 Department of Biostatistics and Data Science (CDL), Biochemistry (TDH) and the Center for Precision Medicine, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USABackground 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.https://bmjopen.bmj.com/content/15/2/e094322.full |
| spellingShingle | Daniel Woo Richard Thompson Carl D Langefeld Nichol McBee Daniel Hanley Matthew L Flaherty Lauren Sansing Karen Lane Lee A Gilkerson Achala Vagal Nathan Walborn Wendy Ziai Noeleen Ostapkovich Kevin Triene Timothy David Howard The REpeated ASSEssment of SurvivorS in intracerebral haemorrhage: protocol for a multicentre, prospective observational study BMJ Open |
| title | The REpeated ASSEssment of SurvivorS in intracerebral haemorrhage: protocol for a multicentre, prospective observational study |
| title_full | The REpeated ASSEssment of SurvivorS in intracerebral haemorrhage: protocol for a multicentre, prospective observational study |
| title_fullStr | The REpeated ASSEssment of SurvivorS in intracerebral haemorrhage: protocol for a multicentre, prospective observational study |
| title_full_unstemmed | The REpeated ASSEssment of SurvivorS in intracerebral haemorrhage: protocol for a multicentre, prospective observational study |
| title_short | The REpeated ASSEssment of SurvivorS in intracerebral haemorrhage: protocol for a multicentre, prospective observational study |
| title_sort | repeated assessment of survivors in intracerebral haemorrhage protocol for a multicentre prospective observational study |
| url | https://bmjopen.bmj.com/content/15/2/e094322.full |
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