Application of Circulating Exosomes in Early Diagnosis an... | NCT05035134

Studies
Application of Circulating Exosomes in Early Diagnosis and Prognosis Evaluation After Intracerebral Hemorrhage

NCT05035134

Sponsor

Tang-Du Hospital

Status

Unknown status

Last Update Posted

Sep 5, 2021Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Intracerebral Hemorrhage；Circulating Exosomes

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

Aug 2021

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

Sep 12, 2021Estimated

Primary Completion Date

Jul 31, 2022Estimated

Completion Date

Jul 31, 2022Estimated

First Submitted Date

Jul 26, 2021

First Submission Date that Met QC Criteria

Aug 31, 2021

First Posted Date

Sep 5, 2021Actual

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

Aug 31, 2021

Last Update Posted Date

Sep 5, 2021Actual

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 purpose of this study is to observe the relationship between the changes of circulating exosomes and the development and outcome of the disease in patients with intracerebral hemorrhage, and to search for early serum markers and potential intervention targets for disease monitoring in patients with intracerebral hemorrhage

Detailed Description

Not provided

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The type and content of circulating exosomes	After the exosomes were isolated, RNA sequencing and proteome sequencing were performed to identify the change of circulating exosomes	within 24 hours of ICH
Modified Rankin scale (mRS) scores	mRS scores was divided into seven grades (0-6). The higher the score, the more severe the symptoms	from onset to three months or six months

Secondary Outcomes

Measure	Description	Time Frame
mortality		through study completion，an average of 1 year
hospital stay		From hospitalization to discharge，up to one month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

No systematic treatment was given before admission;
The patients were diagnosed with cerebral hemorrhage, and had imaging evidence;
The age was more than 18 years old;
The patient or family member agrees to sign the informed consent.

Exclusion Criteria:

Hematoma is caused by secondary factors (intracranial tumor, arteriovenous malformation or aneurysm);
Bleeding into the ventricle;
Multiple cerebral hemorrhage;
The patient did not receive treatment in our hospital;
Severe disability, dementia, or organ dysfunction before onset
Coagulopathy or long-term use of anticoagulants
Hematoma affects brain stem
Subjects refused to participate

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

All of the ICH patients receiving treatment in Tangdu Hospital during 2021-2022

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xun Wu, M.D	Contact	86-15609261331		2645302700@qq.com

Overall Officials

Name	Affiliation	Role
Yan Qu, M.D, Ph.D	Tang-Du Hospital	Study Chair
Xun Wu, M.D	Tang-Du Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tandu Hospital, Fourth Military Medical University	Recruiting	Xi'an			China