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

Not yet recruiting

• Conditions: Intracerebral Hemorrhage; Hemorrhage; Neurologic Deficits; Hemorrhagic Stroke

• Registration Number: NCT05502874
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-07-31
• Study First Submitted QC: 2022-08-14
• Last Update Submitted: 2022-08-14
• Study First Posted: 2022-08-16
• Last Update Posted: 2022-08-16
• Study Start: 2022-09-01
• Primary Completion: 2024-12-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1600

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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
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.
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.
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.

Trial Locations

Locations (1)

2nd Affiliated Hospital, School of Medicine at Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China