Multiomic Analysis of Body Fluid in Acute Traumatic Brain Injury

NCT ID: NCT05778123

Last Updated: 2023-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-12-31

Brief Summary

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The goal of this experimental observation study is to figure out differently expressed biomarkers in body fluid in traumatic brain injury patients. The main questions it aims to answer is:

* Which RNA, protein and metabolites are differently expressed in lesion tissues?
* What molecular mechanism is participated in TBI? Participants will be treated by emergency operation, and their body fluid samples will be collected in emergency room and during the operation.

Detailed Description

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Conditions

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Brain Injuries, Traumatic

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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TBI

Patients with traumatic brain injury.

Type of disease

Intervention Type OTHER

Different types of pathogen: brain injury by trauma or hydrocephalus due to various diseases.

Control

Patients with hydrocephalus.

Type of disease

Intervention Type OTHER

Different types of pathogen: brain injury by trauma or hydrocephalus due to various diseases.

Interventions

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Type of disease

Different types of pathogen: brain injury by trauma or hydrocephalus due to various diseases.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age \>18 and \<65
2. Within 12 hours after brain injury
3. Control group is hydrocephalus
4. GCS ≥3 and ≤8
5. Closed brain injury with frontotemporal contusion
6. Need emergency intracranial hematoma evacuating or cerebrospinal fluid shunting operation
7. Patient's agents are informed and consent the research

Exclusion Criteria

1. With TBI, stroke, ICH or intracranial tumor history
2. Death within 24 hours
3. Immunosuppression state
4. Severe organ dysfunction
5. Complicated infective disease
6. Pregnant
Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Junfeng Feng

Director of Brain Injury Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhenghui He

Role: CONTACT

+8613585916217

Facility Contacts

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Junfeng Feng

Role: primary

+8613611860825

Other Identifiers

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LY2023-018-B

Identifier Type: -

Identifier Source: org_study_id

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