A Cohort Study of Patients With Intracranial Hemorrhage

Intracerebral Hemorrhage Clinical Trial

Official title:

China Cohort of Patients With Intracranial Hemorrhage

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05760950
• Other study ID #: Cohort Study for ICH
• Status: Recruiting
• Start date: December 11, 2020
• Est. completion date: June 1, 2023

Study information

• Verified date: February 2023
• Source: Capital Medical University
• Contact: Xunming Ji
• Phone: 010-83199430
• Email: jixm[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage
• Intracranial Hemorrhages

Intervention

Other:
• Routine clinical treatment
Routine clinical treatment is based on the latest international guidelines for intracerebral hemorrhage.

Locations

Country	Name	City	State
China	Xuan Wu Hospital,Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

References & Publications (2)

Greenberg SM, Ziai WC, Cordonnier C, Dowlatshahi D, Francis B, Goldstein JN, Hemphill JC 3rd, Johnson R, Keigher KM, Mack WJ, Mocco J, Newton EJ, Ruff IM, Sansing LH, Schulman S, Selim MH, Sheth KN, Sprigg N, Sunnerhagen KS; American Heart Association/Ame — View Citation

Jolink WM, Klijn CJ, Brouwers PJ, Kappelle LJ, Vaartjes I. Time trends in incidence, case fatality, and mortality of intracerebral hemorrhage. Neurology. 2015 Oct 13;85(15):1318-24. doi: 10.1212/WNL.0000000000002015. Epub 2015 Sep 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional outcome	evaluated by modified Rankin Scale	90-day
Secondary	Neurological deterioration	evaluated by NIHSS or GCS	14-day
Secondary	Functional outcome	evaluated by modified Rankin Scale	1-year
Secondary	Cerebrovascular disease event	ischemic and hemorrhagic events	2-year