Hemorrhage, Hemorrhagic Stroke, Intracerebral Hemorrhage, Neurologic Deficits
Conditions
Keywords
Intracerebral Hemorrhage, Neurological Deterioration, Neuroimaging, Prognosis
Brief summary
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
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.
Interventions
None listed
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early neurological deterioration (END) | 48 hours after admission | END is defined as an increase in the total NIHSS score of ≥ 4 points within the first 48 h after admission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional outcome | 90 days, 1 year, 2 years after admission | Functional outcome will be assessed with modified ranking scale(mRS).Poor outcome is defined as mRS 4-6 at follow-up |
| Hematoma expansion | 24 hours after admission | Hematoma volume expansion of at least 6 mL or 33% on a CT scan obtained 24 hours after admission compared with the entry scan. |
| Late neurological deterioration (LND) | 7 days | LND is defined as an increase in the total NIHSS score of ≥ 4 points between 48h and 7 days after admission |
| Depression status | 90 days, 1 year, 2 years after admission | Patient Health Questionnaire (PHQ)-9 scale will be evaluated, and higher scores means a worse status. |
| Cognitive function | 90 days, 1 year, 2 years after admission | Telephone Interview for Cognitive Status-Modified(TICS-m) scale will be evaluated via telephone interview. |
| The quality of life | 90 days, 1 year, 2 years after admission | The quality of life will be assessed with the EuroQol-5D (EQ-5D) scale. |
Countries
China
Contacts
Primary ContactFeng Gao, MD,PhD
Backup ContactLusha Tong, MD,PhD
Outcome results
None listed