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

Hemorrhage Clinical Trial

— CATCH  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05502874
• Other study ID #: 08268522
• Status: Not yet recruiting
• Start date: September 1, 2022
• Est. completion date: October 1, 2025

Study information

• Verified date: July 2022
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Feng Gao, MD,PhD
• Phone: 13588451471
• Email: 2202012[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1600
• Est. completion date: October 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Hemorrhagic Stroke
• Intracerebral Hemorrhage
• Neurologic Deficits
• Neurologic Manifestations

Locations

Country	Name	City	State
China	2nd Affiliated Hospital, School of Medicine at Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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