Prospective Cohort Study of Intracerebral Hemorrhage

NCT04707105 | Recruiting

• 1 other identifier: I2018001098
• Study Type: observational
• Target: 856
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators design a prospective, observational cohort study to provide contemporary information on the prevalence, characteristics, risk stratification，cost-effective ,treatments and prognosis of Chinese hospitalised 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

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

Study Population

856 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；
• surgical evacuation of hematoma；
• 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

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

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: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 13, 2021
• Study Start: December 29, 2020
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 18, 2021

Record last verified: 2021-01

Locations

CN (1)