Multiomic Analysis of Traumatic Brain Injury and Hypertension Intracranial Hemorrhage Lesion Tissue

Brain Injury Traumatic Severe Clinical Trial

— MOSS-THINK  

Official title:

Multiomic Analysis of Traumatic Brain Injury and Hypertension Intracranial Hemorrhage Lesion Tissue

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05778110
• Other study ID #: LY2023-017-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, MD
• 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 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.

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. 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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Brain Injury Traumatic Severe
• Hemorrhage
• Hypertension
• Intracranial Hemorrhage, Hypertensive
• Intracranial Hemorrhages
• Intracranial Hypertension
• Wounds and Injuries

Intervention

Other:
• Type of disease
Different types of pathogen: brain injury by trauma or intracranial hemorrhage due to hypertension.

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 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
Primary	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
Primary	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