Clinical Outcomes Following Primary Intracerebral Hemorrhage (COPI)

Clinical Outcomes Following Primary Intracerebral Hemorrhage：A Multicenter Cohort Study

The investigators design an observational multi-center cohort study to provide contemporary information on the prevalence, characteristics, risk stratification，cost-effective ,treatments and prognosis of Chinese hospitalized adult patients with primary intracerebral hemorrhage.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Intracerebral Hemorrhage

Detailed Description

This cohort was an analysis based on patients from six stroke centers: the 2nd Affiliated Hospital of Zhejiang University; the First People's Hospital of Pinghu, Jiaxing; the First People's Hospital of Taizhou; the People's Hospital of Haiyan, Jiaxing; Tiantai County People's Hospital, Taizhou; the 2nd People's Hospital of Quzhou (Please see more information of this cohort in supplement). All hospitals are located in Zhejiang Province. Patients' data were entered by local trained registrars using standardised protocols, and the overall process of case registration, monitoring of the data quality, and inquiry and correction of erroneous data was managed and supervised by a steering committee.

We included adult patients who (1) admitted for primary ICH ; (2) underwent blood routine test (hemoglobin included) and CT scan as soon as they arrived at hospital; (3) were not treated with neurosurgical procedures. We excluded patients who (1) had ICH secondary to known causes, including trauma, intracranial neoplasm and systemic diseases12, as well as anticoagulative agents; or had isolated intraventricular hemorrhage (IVH); (2) mRS >2 before the current ICH episode (according to past medical records or description from guardians.

This study was approved by human research ethic committees at all participating centers, and conducted in compliance with the principles set forward by the Declaration of Helsinki.

• Study Type: Observational
• Enrollment (Estimated): 25000

Contacts and Locations

• Study Contact: Name: Feng Gao, Dr; Phone Number: +86-13588451471; Email: 2202012@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • The Second Affiliated Hospital of Zhejiang University
      • Contact: Feng Gao, Dr; Phone Number: +86-13588451471; Email: 2202012@zju.edu.cn
      • Principal Investigator: Feng Gao, Dr
      • Sub-Investigator: Lusha Tong, Dr
      • Sub-Investigator: Jiawen Li, Dr
      • Sub-Investigator: Yujia Jin, Dr
      • Sub-Investigator: Lili Tang, MD
      • Sub-Investigator: Kaicheng Yang, MD
      • Sub-Investigator: Qing Lin, Dr
      • Sub-Investigator: Zaijun Song, MD
      • Sub-Investigator: Hongna An, MD
      • Sub-Investigator: Guoshen Yu, MD
      • Sub-Investigator: Jian Wu, MD
      • Sub-Investigator: Xianghua Ye, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with acute primary intracerebral hemorrhage

Description

Inclusion Criteria:

- We included adult patients who (1) admitted for primary ICH ; (2) underwent blood routine test (hemoglobin included) and CT scan as soon as they arrived at hospital; (3) were not treated with neurosurgical procedures.

Exclusion Criteria:

• We excluded patients who (1) had ICH secondary to known causes, including trauma, intracranial neoplasm and systemic diseases12, as well as anticoagulative agents; or had isolated intraventricular hemorrhage (IVH); (2) mRS >2 before the current ICH episode (according to past medical records or description from guardians.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Patients with primary intracerebral hemorrhage; We included adult patients who (1) admitted for primary ICH; (2) underwent blood routine test (hemoglobin included) and CT scan as soon as they arrived at hospital; (3) were not treated with neurosurgical procedures. We excluded patients who (1) had ICH secondary to known causes, including trauma, intracranial neoplasm and systemic diseases, as well as anticoagulative agents; or had isolated intraventricular hemorrhage (IVH); (2) mRS >2 before the current ICH episode (according to past medical records or description from guardians.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause death	Patients die of any reasons	5 years after ICH
ICH recurrence	Patients had an another ICH after this ictus	5 years after ICH
3-month outcome	3-month outcome is measured using modified Rankin Scale (mRS) score	3 months after ICH

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hematoma volume	The volume of hematoma according to CT scan at the baseline when patients arrived at the emergency room	up to 5 hours (A few hours after ICH)
hematoma expansion	Patients had another CT scan during 24-48 hours after the first CT, and hematoma volume growth exceeding 33% or absolute hematoma growth exceeding 6ml	within 48 hours after ICH
cerebral small vessel diseases (CSVDs)	cerebral small vessel diseases evaluated by MRI, including cortical superficial siderosis (cSS), white matter hyperintensity (WMH), cerebral microbleed (CMB), etc.	within 2 weeks after ICH

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: Taizhou First People's Hospital; The People's Hospital of Haiyan; The First People's Hospital of Pinghu; The 2nd People's Hospital of Quzhou
• Investigators: Study Chair: Feng Gao, Dr, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2016
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2033

Study Registration Dates

• First Submitted: August 8, 2024
• First Submitted That Met QC Criteria: August 9, 2024
• First Posted (Actual): August 12, 2024

Study Record Updates

• Last Update Posted (Actual): August 12, 2024
• Last Update Submitted That Met QC Criteria: August 9, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Stroke; Outcomes; Primary intracerebral hemorrhage
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage
• Other Study ID Numbers: ZJU

Drug and device information, study documents

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