CClinicalTrials.gg
RecruitingNCT05778110MOSS-THINKUpdated May 3, 2023

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

An observational study in Brain Injury Traumatic Severe and Intracranial Hemorrhage, Hypertensive, sponsored by RenJi Hospital. Recruiting at 1 site in China. Open to participants aged 16 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-05-03.

Sponsored by RenJi Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2024, 2 years 6 months ago, but the record still lists the study as recruiting.
  • Started Apr 2023; still recruiting 3 years 6 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
10
Ages
16 Years to 65 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Brain Injury Traumatic Severe
  • Intracranial Hemorrhage, Hypertensive

Keywords

  • Traumatic brain injury
  • Hypertensive intracranial hemorrhage
  • Multiomic analysis
  • Biomarker
  • Molecular mechanism
03

In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's planned enrollment of 10 is below the median of 100 across 690 observational studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with severe traumatic brain injury or hypertensive intracranial hemorrhage.

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

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
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
10 participants (estimated)
Patient registry
No

Groups and cohorts

  • TBI

    Patients with traumatic brain injury.

    Other: Type of disease

  • ICH

    Patients with hypertensive intracranial hemorrhage.

    Other: Type of disease

Interventions

  • OtherType of disease

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Immediately after collecting tissues

  2. 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.

    Time frame: Immediately after collecting tissues

  3. 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.

    Time frame: Immediately after collecting tissues

07

Study locations

1 of 1 sites recruiting
  • Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
    Shanghai, Shanghai, China
    • Junfeng Feng · Contact · +8613611860825
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05778110
Lead sponsor
RenJi Hospital
Responsible party
Junfeng Feng (Director of Brain Injury Center, RenJi Hospital) — Principal investigator
First posted
Mar 21, 2023
Start date
Apr 1, 2023
Primary completion
Mar 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
May 3, 2023

Study contacts

Zhenghui He, MD
Contact
hezhenghui8@hotmail.com
+8613585916217

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion