Chongqing Intracerebral Hemorrhage Study | NCT03085472

Studies
Chongqing Intracerebral Hemorrhage Study

NCT03085472

Sponsor

First Affiliated Hospital of Chongqing Medical University

Status

Unknown status

Last Update Posted

Mar 21, 2017Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Intracerebral Hemorrhage
Stroke
Hematoma

Interventions

Not provided

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

Mar 2017

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

Feb 16, 2017Actual

Primary Completion Date

Feb 1, 2019Estimated

Completion Date

Jan 1, 2023Estimated

First Submitted Date

Mar 1, 2017

First Submission Date that Met QC Criteria

Mar 15, 2017

First Posted Date

Mar 21, 2017Actual

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

Mar 15, 2017

Last Update Posted Date

Mar 21, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Qi Li, Professor, First Affiliated Hospital of Chongqing Medical UniversityPrincipal Investigator

Lead Sponsor

First Affiliated Hospital of Chongqing 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

The Chongqing intracerebral hemorrhage study is a multi-center, prospective, observational study led by professor Qi Li from Chongqing Medical University. Professor Peng Xie will be the senior consultant for the study. The Chongqing intracerebral hemorrhage study will focus on the epidemiology, natural history, pathogenesis, laboratory, radiological aspects, clinical outcomes and the effects of treatment in patients with intracerebral hemorrhage.

The clinical, laboratory, imaging, genetic and outcome data of patients diagnosed with acute intracerebral hemorrhage will be prospectively collected. The prognosis of patients with intracerebral hemorrhage will be assessed by using several outcome measure scales at different time points.

Detailed Description

The Chongqing intracerebral hemorrhage study will try to address several key issues in ICH. The baseline clinical data including demographic, disease severity scores, prior drug history and relevant medical history, premorbid mRS scores will be prospectively recorded. The admission and follow-up imaging data of all registered patients will be saved as Dicom format for future use and review. The functional outcomes will be assessed and recorded by experienced neurologists.

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

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
benigh hematoma		Patients with novel imaging markers or clinical features suggestive of a relatively benigh hematoma (less likely to expand and have a relatively good outcome).
malignant hematoma		Patients with novel imaging markers or clinical features suggestive of a relatively bad hematoma (more likely to expand and have a relatively poor outcome).

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
hematoma volume growth at 24 hours	To assess early hematoma volume growth at 24 hours	24 hours

Secondary Outcomes

Measure	Description	Time Frame
functional outcome at 3 months assessed by modified Ranking Scale	assess functional outcome at 3months using mRS	3 months
early neurological deterioration assessed by NIHSS score at 24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age >= 18 years
Informed consent to participate in the study
Patients diagnosed with CT-confirmed spontaneous Intracerebral Hemorrhage (ICH)
Patients are willing to participate in the follow up assessment

Exclusion Criteria:

Did not agree to participate in the study
Secondary ICH to hemorrhagic infarction or tumor bleeding etc.
Traumatic ICH

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

18 Years and older (Adult patients)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Qi Li, MD;PhD	Contact	86 18523381983		qili_md@126.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital of Chongqing Medical University	Recruiting	Chongqing		400016	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002543	Cerebral Hemorrhage
D020521	Stroke
D006406	Hematoma

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided