A Cohort Study of Patients With Intracranial Hemorrhage

Recruiting

• Conditions: Intracerebral Hemorrhage

• Registration Number: NCT05760950
• Lead Sponsor: Capital Medical University

Brief Summary

As one of the most serious forms of acute stroke, the early mortality rate of intracerebral hemorrhage(ICH) can be as high as 30-40%. The incidence of intracerebral hemorrhage increases with the increase of age. Under the circumstance of the aggravation of aging in China, intracerebral hemorrhage brings a certain burden to families and society.

The results of several studies in recent years have failed to provide new therapeutic approaches for the treatment of cerebral hemorrhage. Therefore, novel therapeutic approaches is urgently needed for ICH. Primary and secondary prevention, acute inpatient care, and poststroke rehabilitation are all critical. The objective of this cohort study is to explore factors that might influence the long-term prognosis of patients with ICH and to further identify new potential targets for intervention.

Detailed Description

The observational cohort study will be used to find the possible treatment methods and predictors of functional outcome. The medical records of patients will be collected, including age, sex, comorbid conditions, toxic habits, use of medications (antiplatelets, anticoagulants, and antihypertensives), systolic and diastolic blood pressure, Glasgow Coma Scale (GCS) score, and National Institutes of Health Stroke Scale (NIHSS) score on admission. Image data will also be collected. Follow-up information will be obtained from the medical records or telephone interviews.

Study Timeline

• Study Start: 2020-12-11
• Status Verified: 2023-02
• Study First Submitted: 2023-02-27
• Study First Submitted QC: 2023-02-27
• Last Update Submitted: 2023-02-27
• Study First Posted: 2023-03-09
• Last Update Posted: 2023-03-09
• Primary Completion: 2023-05-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Primary intracerebral hemorrhage
• Over 18 year-old

Exclusion Criteria

• Secondary intracerebral hemorrhage, such as aneurysmal, hemorrhagic transformation of ischemic stroke, cavernomas, arterio-venous malformations, central venous thrombosis, trauma-related, or tumor.
• Pregnant patients.
• Any condition which, in the judgment of the investigator, might increase the risk to the patient.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional outcome	90-day	evaluated by modified Rankin Scale

Secondary Outcome Measures

Name	Time	Method
Neurological deterioration	14-day	evaluated by NIHSS or GCS
Functional outcome	1-year	evaluated by modified Rankin Scale
Cerebrovascular disease event	2-year	ischemic and hemorrhagic events

Trial Locations

Locations (1)

Xuan Wu Hospital，Capital Medical University; 🇨🇳 Beijing, Beijing, China