Retrospective Cohort Study of Intracerebral Hemorrhage

NCT04803292 | Unknown

• 1 other identifier: I20200011153
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Intracerebral Hemorrhage

Keywords

primary intracerebral hemorrhage; hypertension; perihematomal edema; secondary brain injury; remote diffusion-weighted imaging lesions(R-DWILs); immune response; multimodel image; cohort; MRI

Outcome Measures

Primary Outcomes (1)

• proportion of patients with a 3-month modified Rankin Scale (mRS) score≤ 3 proportion of patients with a 3-month modified Rankin Scale (mRS) score≤ 3 proportion of patients with a 3-month modified Rankin Scale (mRS) score≤ 3

  mRS 0-6, higher indicate worse outcome

  2-3years

Secondary Outcomes (3)

• Absolute peripheral hematoma edema(PHE) growth

  2-3years

• Relative peripheral hematoma edema(rPHE)

  2-3years

• National institute of health stroke scale（NIHSS score）

  2-3years

Study Arms (3)

Second Affiliated Hospital, School of Medicine, Zhejiang University

a prospective cohort of patients of primary intracerebral hemorrhage in Second Affiliated Hospital, School of Medicine, Zhejiang University

Second People's Hospital of Hangzhou City, Zhejiang Province

a prospective cohort of patients of primary intracerebral hemorrhage in Second People's Hospital of Hangzhou City, Zhejiang Province

4th Affiliated Hospital, School of Medicine at Zhejiang University

a prospective cohort of patients of primary intracerebral hemorrhage in 4th Affiliated Hospital, School of Medicine at Zhejiang University

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Hospitalized patients over 18 years old of primary intracerebral hemorrhage.

You may not qualify if:

• patients of secondary intracerebral hemorrhage，such as hemorrhagic transformation of ischemic stroke, aneurysmal, cavernomas, arterio- venous malformations, central venous thrombosis, trauma-related, or tumor
• isolated intraventricular hemorrhage or subarachnoid hemorrhage pregnant patients
• unavailability to get complete blood cell samples and presenting contraindications or refusal to MRI
• patients cannot be followed up for any reasons.
• patients death in 24 hours
• pregnant patients
• surgical evacuation of hematoma

Sponsors & Collaborators

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

Study Sites (1)

2nd Affiliated Hospital, School of Medicine at Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (3)

• Jin Y, Huang YH, Chen YP, Zhang YD, Li J, Yang KC, Ye X, Jin LH, Wu J, Yuan CZ, Gao F, Tong LS. Combined effect of cortical superficial siderosis and cerebral microbleed on short-term and long-term outcomes after intracerebral haemorrhage. Stroke Vasc Neurol. 2024 Aug 27;9(4):429-438. doi: 10.1136/svn-2023-002439.

  PMID: 37949481 DERIVED

• Jin YJ, Li JW, Wu J, Huang YH, Yang KC, An HN, Yuan CZ, Gao F, Tong LS. Cortical superficial siderosis, hematoma volume, and outcomes after intracerebral hemorrhage: a mediation analysis. Front Neurol. 2023 May 5;14:1122744. doi: 10.3389/fneur.2023.1122744. eCollection 2023.

  PMID: 37213900 DERIVED

• Li J, Shen D, Zhou Y, Jin Y, Jin L, Ye X, Tong L, Gao F. Underlying microangiopathy and functional outcome of simultaneous multiple intracerebral hemorrhage. Front Aging Neurosci. 2022 Nov 8;14:1000573. doi: 10.3389/fnagi.2022.1000573. eCollection 2022.

  PMID: 36425320 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood

MeSH Terms

Conditions

Cerebral Hemorrhage; Hypertension

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Feng Gao, MD,PhD

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng Gao, MD,PhD

CONTACT

13588451471; 2202012@zju.edu.cn

Lusha Tong, MD,PhD

CONTACT

15868171218

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 17, 2021
• Study Start: January 1, 2012
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2025
• Last Updated: March 17, 2021

Record last verified: 2021-02

Locations

CN (1)