A Cohort Study of Patients With Intracranial Hemorrhage

Sponsor
Capital Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05760950
Collaborator
(none)
300
1
29.6
10.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Routine clinical treatment

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 Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
China Cohort of Patients With Intracranial Hemorrhage
Actual Study Start Date :
Dec 11, 2020
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Functional outcome [90-day]

    evaluated by modified Rankin Scale

Secondary Outcome Measures

  1. Neurological deterioration [14-day]

    evaluated by NIHSS or GCS

  2. Functional outcome [1-year]

    evaluated by modified Rankin Scale

  3. Cerebrovascular disease event [2-year]

    ischemic and hemorrhagic events

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Xuan Wu Hospital,Capital Medical University Beijing Beijing China 100069

Sponsors and Collaborators

  • Capital Medical University

Investigators

  • Principal Investigator: Xunming Ji, Study Principal Investigator Xuanwu Hospital, Beijing

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ji Xunming,MD,PhD, Professor, Capital Medical University
ClinicalTrials.gov Identifier:
NCT05760950
Other Study ID Numbers:
  • Cohort Study for ICH
First Posted:
Mar 9, 2023
Last Update Posted:
Mar 9, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 9, 2023