Clinical trial Recruiting at 1 site Observational

Collecting and analyzing clinical and molecular data in patients with traumatic brain injury

Official title: Clinical and Molecular Biological Data Collection and Analysis in Patients With Traumatic Brain Injury (TBI)

Run by Shanghai 6th People's Hospital · NCT05533060 · Data updated 2026-11-12

This study is testing if collecting detailed health information and brain tissue samples from patients with traumatic brain injury can help doctors better predict recovery and outcomes.

Quick facts

Study typeObservational
SexAll
Enrollment200 (estimated)
SponsorShanghai 6th People's Hospital
Academic / other
Locations1 site (Shanghai)
StatusRecruiting
StartedSeptember 1, 2022
Main results expectedDecember 30, 2027
Study endsDecember 30, 2027
Registry record updatedMay 6, 2025
Trial IDNCT05533060 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include patients with CT/MRI confirmed TBI who are within 12 hours of injury and meet specific clinical criteria.

Probably not a fit

Patients who are not suitable for surgery or have severe pre-existing conditions may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to improve the evaluation and prognosis prediction of patients with traumatic brain injury (TBI) by collecting and analyzing clinical data alongside molecular biomarkers obtained through single-cell sequencing. Eligible patients will undergo surgical treatment, during which brain tissue will be preserved for further analysis. The study will utilize high-throughput sequencing and bioinformatics to identify significant biomarkers and compare them with existing evaluation methods. The goal is to develop a regression model that correlates neurological status with various clinical factors, enhancing the accuracy of patient outcome predictions.

Why it matters

Potential benefit: If successful, this study could lead to more accurate assessments and better prognostic predictions for patients with traumatic brain injury.

How similar studies have gone: While there have been studies focusing on molecular biomarkers in TBI, this specific approach combining clinical data with single-cell sequencing is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* CT/MRI confirmed TBI;
* The time from onset to the emergency room (ER ) within 12h;
* The systolic pressure (SBP) ≥ 90 mmHg;
* Patients willing to participate in this study with signed informed consent.

Exclusion Criteria:

* Patients who are not suitable for surgery (GCS score 3 points, dilated and fixed bilateral pupils, pregnant women, etc.);
* Pre-injury life expectancy ≤ 1 year (malignant tumor);
* Previous history of acute myocardial infarction, abnormal immune function, and blood-related diseases;
* without informed consent.

Where it's running

  • Shanghai 6th People's Hospital
    Shanghai, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.