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

Sponsor
RenJi Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05778110
Collaborator
(none)
10
21

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Type of disease

Study Design

Study Type:
Observational
Anticipated Enrollment :
10 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Multiomic Analysis of Traumatic Brain Injury and Hypertension Intracranial Hemorrhage Lesion Tissue
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 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.

Outcome Measures

Primary Outcome Measures

  1. RNA biomarkers in TBI or ICH patients' lesion tissues assessed by transcriptome bioinformatic analysis [Immediately after collecting tissues]

    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.

  2. Protein biomarkers in TBI or ICH patients' lesion tissues assessed by proteomic bioinformatic analysis [Immediately after collecting tissues]

    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.

  3. Metabolite biomarkers in TBI or ICH patients' lesion tissues assessed by metabolomic bioinformatic analysis [Immediately after collecting tissues]

    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.

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. 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

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:
NCT05778110
Other Study ID Numbers:
  • LY2023-017-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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 21, 2023