Multiomic Analysis of Body Fluid in Acute Traumatic Brain Injury

Recruiting

• Conditions: Brain Injuries, Traumatic
• Interventions: Other: Type of disease

• Registration Number: NCT05778123
• Lead Sponsor: RenJi Hospital

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2023-02-05
• Study First Submitted QC: 2023-03-17
• Study First Posted: 2023-03-21
• Study Start: 2023-04-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-01
• Last Update Posted: 2023-05-03
• Primary Completion: 2024-03-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TBI	Type of disease	Patients with traumatic brain injury.
Control	Type of disease	Patients with hydrocephalus.

Primary Outcome Measures

Name	Time	Method
Metabolite biomarkers in patients' blood & cerebrospinal fluid assessed by metabolomic bioinformatic analysis	Immediately after collecting blood & cerebrospinal fluid	Patients' blood and cerebrospinal fluid will be collected in emergency room and operation room respectively. Then these samples will be immediately prepared to be detected through metabolomic mass spectrometry. The results of metabolomic will be further analyzed and compared with control group to filter potential metabolite biomarkers in blood and cerebrospinal fluid of severe TBI patients.
RNA biomarkers in patients' blood & cerebrospinal fluid assessed by transcriptome bioinformatic analysis	Immediately after collecting blood & cerebrospinal fluid	Patients' blood and cerebrospinal fluid will be collected in emergency room and operation room respectively. Then these samples will be immediately prepared to be detected through transcriptome sequencing. The results of transcriptome sequencing will be further analyzed and compared with control group to filter potential RNA biomarkers in blood and cerebrospinal fluid of severe TBI patients.
Protein biomarkers in patients' blood & cerebrospinal fluid assessed by proteomic bioinformatic analysis	Immediately after collecting blood & cerebrospinal fluid	Patients' blood and cerebrospinal fluid will be collected in emergency room and operation room respectively. Then these samples will be immediately prepared to be detected through proteomics mass spectrometry. The results of proteomic will be further analyzed and compared with control group to filter potential protein biomarkers in blood and cerebrospinal fluid of severe TBI patients.

Trial Locations

Locations (1)

Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University; 🇨🇳 Shanghai, Shanghai, China