NCT05760950

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 11, 2020

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 27, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 9, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

March 9, 2023

Status Verified

February 1, 2023

Enrollment Period

2.4 years

First QC Date

February 27, 2023

Last Update Submit

February 27, 2023

Conditions

Intracerebral Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • Functional outcome

    evaluated by modified Rankin Scale

    90-day

Secondary Outcomes (3)

  • Neurological deterioration

    14-day

  • Functional outcome

    1-year

  • Cerebrovascular disease event

    2-year

Interventions

Routine clinical treatmentOTHER

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with spontaneous intracerebral hemorrhage

You may qualify if:

  • Primary intracerebral hemorrhage
  • Over 18 year-old

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuan Wu Hospital，Capital Medical University

Beijing, Beijing Municipality, 100069, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 26377254RESULT

  • 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.

    PMID: 35579034RESULT

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Xunming Ji

    Study Principal Investigator Xuanwu Hospital, Beijing

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xunming Ji

CONTACT

010-83199430jixm@ccmu.edu.cn

Mengke Zhang

CONTACT

zwzmk985@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 27, 2023

First Posted

March 9, 2023

Study Start

December 11, 2020

Primary Completion

May 1, 2023

Study Completion

June 1, 2023

Last Updated

March 9, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)