Multicenter Registry for Assessment of Markers of Early Neurological Deterioration in Primary Intracerebral Hemorrhage
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Intracerebral Hemorrhage
- Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Enrollment
- 1600
- Locations
- 1
- Primary Endpoint
- Early neurological deterioration (END)
- Status
- Not Yet Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Early neurological deterioration (END)
Time Frame: 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 Outcomes
- The quality of life(90 days, 1 year, 2 years after admission)
- Late neurological deterioration (LND)(7 days)
- Cognitive function(90 days, 1 year, 2 years after admission)
- Functional outcome(90 days, 1 year, 2 years after admission)
- Hematoma expansion(24 hours after admission)
- Depression status(90 days, 1 year, 2 years after admission)