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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05502874

Collaborator

(none)

1,600

Enrollment

Location

Anticipated Duration (Months)

43.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intracerebral Hemorrhage Neurologic Deficits Hemorrhagic Stroke Hemorrhage

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 Design

Study Type:

Observational

Anticipated Enrollment :

1600 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Oct 1, 2025

Outcome Measures

Primary Outcome Measures

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

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
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.
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.
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.