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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hemorrhage; Hemorrhagic Stroke; Intracerebral Hemorrhage; Neurologic Deficits

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 Type: Observational
• Enrollment (Anticipated): 1600

Contacts and Locations

• Study Contact: Name: Feng Gao, MD,PhD; Phone Number: 13588451471; Email: 2202012@zju.edu.cn
• Study Contact Backup: Name: Lusha Tong, MD,PhD; Phone Number: 15868171218; Email: 2310040@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • 2nd Affiliated Hospital, School of Medicine at Zhejiang University
      • Contact: Feng Gao, MD,PhD; Phone Number: 13588451471; Email: 2202012@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients over 18 years old with primary intrcerebral hemorrhage will be enrolled consecutively.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): October 1, 2025

Study Registration Dates

• First Submitted: July 31, 2022
• First Submitted That Met QC Criteria: August 14, 2022
• First Posted (Actual): August 16, 2022

Study Record Updates

• Last Update Posted (Actual): August 16, 2022
• Last Update Submitted That Met QC Criteria: August 14, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Prognosis; Neuroimaging; Intracerebral Hemorrhage; Neurological Deterioration
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage; Hemorrhagic Stroke; Neurologic Manifestations
• Other Study ID Numbers: 08268522

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No