Multiomic Analysis of Body Fluid in Acute Traumatic Brain Injury

Brain Injuries, Traumatic Clinical Trial

— MOSS-FAST  

Official title:

Multiomic Analysis of Body Fluid in Acute Traumatic Brain Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05778123
• Other study ID #: LY2023-018-B
• Status: Recruiting
• Start date: April 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: RenJi Hospital
• Contact: Zhenghui He
• Phone: +8613585916217
• Email: hezhenghui8[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
China	Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RNA biomarkers in patients' blood & cerebrospinal fluid assessed by transcriptome bioinformatic analysis	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.	Immediately after collecting blood & cerebrospinal fluid
Primary	Protein biomarkers in patients' blood & cerebrospinal fluid assessed by proteomic bioinformatic analysis	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.	Immediately after collecting blood & cerebrospinal fluid
Primary	Metabolite biomarkers in patients' blood & cerebrospinal fluid assessed by metabolomic bioinformatic analysis	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.	Immediately after collecting blood & cerebrospinal fluid