MOSS-FAST: Multiomic Analysis of Body Fluid in Acute Traumatic Brain Injury

• Sponsor: RenJi Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05778123
• Collaborator: (none)
• Enrollment: 10
• Anticipated Duration (Months): 21

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Injuries, Traumatic	Other: Type of disease

Study Design

• Study Type: Observational
• Anticipated Enrollment: 10 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Multiomic Analysis of Body Fluid in Acute Traumatic Brain Injury
• Anticipated Study Start Date: Apr 1, 2023
• Anticipated Primary Completion Date: Mar 31, 2024
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
TBI Patients with traumatic brain injury.	Other: Type of disease; Different types of pathogen: brain injury by trauma or hydrocephalus due to various diseases.
Control Patients with hydrocephalus.	Other: Type of disease; Different types of pathogen: brain injury by trauma or hydrocephalus due to various diseases.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• RenJi Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Junfeng Feng, Director of Brain Injury Center, RenJi Hospital
• ClinicalTrials.gov Identifier: NCT05778123
• Other Study ID Numbers: LY2023-018-B
• First Posted: Mar 21, 2023
• Last Update Posted: Mar 21, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Junfeng Feng, Director of Brain Injury Center, RenJi Hospital: Traumatic brain injury; Body fluid; Biomarker; Multiomic analysis
• Additional relevant MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries

Study Results

No Results Posted as of Mar 21, 2023