Clinical Outcomes Following Primary Intracerebral Hemorrhage

NCT06548737 | Recruiting DMC

• 1 other identifier: ZJU
• Study Type: observational
• Target: 25,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Intracerebral Hemorrhage

Keywords

Primary intracerebral hemorrhage; Stroke; Outcomes

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• hematoma volume

  up to 5 hours (A few hours after ICH)

• hematoma expansion

  within 48 hours after ICH

• cerebral small vessel diseases (CSVDs)

  within 2 weeks after ICH

Study Arms (1)

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.

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

Patients with acute primary intracerebral hemorrhage

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• The People's Hospital of Haiyan: collaborator
• Taizhou First People's Hospital: collaborator
• The First People's Hospital of Pinghu: collaborator
• The 2nd People's Hospital of Quzhou: collaborator

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

Related Publications (1)

• Jin YJ, Yu GS, Tang LL, Li JW, Lin Q, Wu J, Song ZJ, An HN, Ye XH, Liu CJ, Gao F, Tong LS. Sex-specific hemoglobin thresholds and longitudinal trajectories in intracerebral hemorrhage outcomes: a multicenter cohort study. BMC Neurol. 2025 Jul 10;25(1):287. doi: 10.1186/s12883-025-04254-w.

  PMID: 40640707 DERIVED

MeSH Terms

Conditions

Stroke; Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

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

Study Officials

• Feng Gao, Dr

  Zhejiang University

  STUDY CHAIR

Central Study Contacts

Feng Gao, Dr

CONTACT

+86-13588451471; 2202012@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 12, 2024
• Study Start: October 27, 2016
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2033
• Last Updated: August 12, 2024

Record last verified: 2024-06

Locations

CN (1)