Clinical trial NCT05760950: A Cohort Study of Patients With Intracranial Hemorrhage
Official title: China Cohort of Patients With Intracranial Hemorrhage
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intracerebral Hemorrhage
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2023-03-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with spontaneous intracerebral hemorrhage

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Functional outcome
timeFrame: 90-day
Secondary outcomes:
measure: Neurological deterioration
timeFrame: 14-day
measure: Functional outcome
timeFrame: 1-year
measure: Cerebrovascular disease event
timeFrame: 2-year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuan Wu Hospital，Capital Medical University
state: Beijing
Study officials:
affiliation: Study Principal Investigator Xuanwu Hospital, Beijing
name: Xunming Ji
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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/American Stroke Association. 2022 Guideline for the Management of Patients With Spontaneous Intracerebral Hemorrhage: A Guideline From the American Heart Association/American Stroke Association. Stroke. 2022 Jul;53(7):e282-e361. doi: 10.1161/STR.0000000000000407. Epub 2022 May 17. No abstract available.