Multiomic Analysis of Traumatic Brain Injury and Hypertension Intracranial Hemorrhage Lesion Tissue (MOSS-THINK)

The goal of this experimental observation study is to figure out differently expressed biomarkers in lesion tissues in traumatic brain injury or hypertension intracranial hemorrhage 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 or ICH? Participants will be treated by emergency operation, and their lesion tissues will be collected during the operation.

Study Overview

• Status: Recruiting
• Conditions: Intracranial Hemorrhage, Hypertensive; Brain Injury Traumatic Severe
• Intervention / Treatment: Other: Type of disease

• Study Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

• Study Contact: Name: Zhenghui He, MD; Phone Number: +8613585916217; Email: hezhenghui8@hotmail.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
      • Contact: Junfeng Feng; Phone Number: +8613611860825

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with severe traumatic brain injury or hypertensive intracranial hemorrhage.

Description

Inclusion Criteria:

1. Age >18 and <65
2. Within 12 hours after brain injury
3. GCS ≥3 and ≤8
4. Closed brain injury with frontotemporal contusion or basal ganglia intracranial hemorrhage
5. Need emergency intracranial hematoma evacuating operation
6. 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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TBI; Patients with traumatic brain injury.	Other: Type of disease; Different types of pathogen: brain injury by trauma or intracranial hemorrhage due to hypertension.
ICH; Patients with hypertensive intracranial hemorrhage.	Other: Type of disease; Different types of pathogen: brain injury by trauma or intracranial hemorrhage due to hypertension.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RNA biomarkers in TBI or ICH patients' lesion tissues assessed by transcriptome bioinformatic analysis	Patients' lesion tissue will be collected during hematoma evacuation. Then these tissues will be immediately prepared to be detected through transcriptome sequencing. The results of transcriptome sequencing will be further analyzed by bioinformatic analysis to reveal different RNA expressions in lesion tissues of severe TBI and ICH patients as the potential biomarkers.	Immediately after collecting tissues
Protein biomarkers in TBI or ICH patients' lesion tissues assessed by proteomic bioinformatic analysis	Patients' lesion tissue will be collected during hematoma evacuation. Then these tissues will be immediately prepared to be detected through proteomics mass spectrometry. The results of proteomic will be further analyzed by bioinformatic analysis to reveal different protein expressions in lesion tissues of severe TBI and ICH patients as the potential biomarkers.	Immediately after collecting tissues
Metabolite biomarkers in TBI or ICH patients' lesion tissues assessed by metabolomic bioinformatic analysis	Patients' lesion tissue will be collected during hematoma evacuation. Then these tissues will be immediately prepared to be detected through metabolomic mass spectrometry. The results of metabolomic will be further analyzed by bioinformatic analysis to reveal different metabolite expressions in lesion tissues of severe TBI and ICH patients as the potential biomarkers.	Immediately after collecting tissues

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Anticipated): March 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: February 5, 2023
• First Submitted That Met QC Criteria: March 17, 2023
• First Posted (Actual): March 21, 2023

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: May 1, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Biomarker; Traumatic brain injury; Molecular mechanism; Hypertensive intracranial hemorrhage; Multiomic analysis
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Hypertension; Brain Injuries; Wounds and Injuries; Hemorrhage; Brain Injuries, Traumatic; Intracranial Hemorrhages; Intracranial Hypertension; Intracranial Hemorrhage, Hypertensive
• Other Study ID Numbers: LY2023-017-B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No