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

Second Affiliated Hospital, School of Medicine, Zhejiang University1,600 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,600

Conditions

Intracerebral Hemorrhage Neurologic Deficits Hemorrhagic Stroke Hemorrhage

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

2nd Affiliated Hospital, School of Medicine at Zhejiang University

Hangzhou, Zhejiang, China

Outcomes

Primary Outcomes

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

Time frame: 48 hours after admission

Secondary Outcomes

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

Time frame: 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

Time frame: 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.

Time frame: 24 hours after admission

The quality of life

The quality of life will be assessed with the EuroQol-5D (EQ-5D) scale.

Time frame: 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.

Time frame: 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.

Time frame: 90 days, 1 year, 2 years after admission

Central Contacts

Feng Gao, MD,PhD

CONTACT

13588451471 2202012@zju.edu.cn

Lusha Tong, MD,PhD

CONTACT

15868171218 2310040@zju.edu.cn

Data from ClinicalTrials.gov

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