A Cohort Study of Patients With Intracranial Hemorrhage | NCT05760950

Studies
A Cohort Study of Patients With Intracranial Hemorrhage

NCT05760950

Sponsor

Capital Medical University

Status

Unknown status

Last Update Posted

Mar 9, 2023Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Intracerebral Hemorrhage

Interventions

Routine clinical treatment

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 11, 2020Actual

Primary Completion Date

May 1, 2023Estimated

Completion Date

Jun 1, 2023Estimated

First Submitted Date

Feb 27, 2023

First Submission Date that Met QC Criteria

Feb 27, 2023

First Posted Date

Mar 9, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 27, 2023

Last Update Posted Date

Mar 9, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ji Xunming,MD,PhD, Professor, Capital Medical UniversityPrincipal Investigator

Lead Sponsor

Capital Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Routine clinical treatment	Other	Routine clinical treatment is based on the latest international guidelines for intracerebral hemorrhage.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Functional outcome	evaluated by modified Rankin Scale	90-day

Secondary Outcomes

Measure	Description	Time Frame
Neurological deterioration	evaluated by NIHSS or GCS	14-day
Functional outcome	evaluated by modified Rankin Scale	1-year

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with spontaneous intracerebral hemorrhage

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xunming Ji	Contact	010-83199430		jixm@ccmu.edu.cn
Mengke Zhang	Contact			zwzmk985@126.com

Overall Officials

Name	Affiliation	Role
Xunming Ji	Study Principal Investigator Xuanwu Hospital, Beijing	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xuan Wu Hospital，Capital Medical University	Recruiting	Beijing	Beijing Municipality	100069	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26377254	Result	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.
35579034	Result	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.

ID	Term
D020300	Intracranial Hemorrhages
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases