Multicenter Registry for Assessment of Markers of Early Neurological Deterioration in Primary Intracerebral Hemorrhage

Study Overview
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Brief Summary
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This multicenter observational study will explore the risk factors of early neurological deterioration(END) in patients with primary and to investigate the association between END and outcome.

Detailed Description
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Neurological deterioration affects approximately one-third of patients with primary intracerebral hemorrhage (ICH) and increases the risk of death and dependency. However, the risk factors of early neurological deterioration (END), such as biochemical parameters, neuroimaging, and systemic complications, are not well documented in primary ICH, and the effective predictors of END is unknown. This multicenter observational study aims to seek out the risk factors of END in patients with primary ICH and to investigate the association between END and outcome.

Official Title
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Multicenter Registry for Assessment of Markers of Early Neurological Deterioration in Primary Intracerebral Hemorrhage

Conditions
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Intracerebral Hemorrhage, Neurologic Deficits, Hemorrhagic Stroke, Hemorrhage

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed diagnosis of primary intracerebral hemorrhage Exclusion Criteria: Patients with secondary Undergo surgical evacuation of hematoma； Presenting contraindications or refusal to MRI Is pregnant Patients refuse to be followed up for any reasons.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early neurological deterioration (END) | END is defined as an increase in the total NIHSS score of ≥ 4 points within the first 48 h after admission | 48 hours after admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late neurological deterioration (LND) | LND is defined as an increase in the total NIHSS score of ≥ 4 points between 48h and 7 days after admission | 7 days | 
| Functional outcome | Functional outcome will be assessed with modified ranking scale(mRS).Poor outcome is defined as mRS 4-6 at follow-up | 90 days, 1 year, 2 years after admission | 
| Hematoma expansion | Hematoma volume expansion of at least 6 mL or 33% on a CT scan obtained 24 hours after admission compared with the entry scan. | 24 hours after admission | 
| The quality of life | The quality of life will be assessed with the EuroQol-5D (EQ-5D) scale. | 90 days, 1 year, 2 years after admission | 
| Depression status | Patient Health Questionnaire (PHQ)-9 scale will be evaluated, and higher scores means a worse status. | 90 days, 1 year, 2 years after admission | 
| Cognitive function | Telephone Interview for Cognitive Status-Modified(TICS-m) scale will be evaluated via telephone interview. | 90 days, 1 year, 2 years after admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intracerebral Hemorrhage, Neurological Deterioration, Neuroimaging, Prognosis