Clinical and Molecular Biological Data Collection and Analysis in Patients With TBI

Last updated: May 3, 2025
Sponsor: Shanghai 6th People's Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neurologic Disorders

Traumatic Brain Injury

Memory Loss

Treatment

No intervention

Clinical Study ID

NCT05533060
2022-KY-13(K)
  • All Genders

Study Summary

Clinical evaluation is crucial in the clinical diagnosis, treatment, and prognosis prediction in patients with traumatic brain injury (TBI). However, the existing evaluation systems are not perfect, because many factors are not taken into account, for example, there is a lack of molecular diagnostic criteria for evaluating patients with TBI. We attempt to collect the patient's clinical data and combine it with neuroimaging, as well as molecular biomarkers generated by single-cell sequencing to assess their neurological status and outcome. The clinical and molecular data collection and analysis will be helpful to evaluate the patient's neurological condition and predict the patient's outcome more accurately.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Patients who are not suitable for surgery (GCS score 3 points, dilated and fixedbilateral pupils, pregnant women, etc.);

  • Pre-injury life expectancy ≤ 1 year (malignant tumor);

  • Previous history of acute myocardial infarction, abnormal immune function, andblood-related diseases;

  • without informed consent.

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: No intervention
Phase:
Study Start date:
September 01, 2022
Estimated Completion Date:
December 30, 2027

Study Description

Specifically, eligible patients will be treated surgically. In one group, injured brain tissue removed during decompression and resection will be preserved in a tissue preservation solution. In another group, brain tissue in the surgical trajectory during surgical resection of the brain lesion (for example, gliomas, meningiomas, schwannomas) will be also preserved in the solution. Then these tissues will be analyzed through high-throughput single-cell sequencing and bioinformatics analysis. In order to obtain the most changed biomarkers, we will pick up the top 10 cell subgroups with 10 expression biomarkers in each subgroup to compare them with the results analyzed in the mice brain tissue. The target biomarkers will be validated in the cerebrospinal fluid (CSF) and blood in patients with TBI for the patient's neurological status evaluation and outcome prediction. At the same time, the patient's pre- and postoperative clinical data (including, gender, age, GCS score, pupil light reflection, CT results, etc) will also be collected. A regression model will be generated to estimate the relationship between the patient's neurological status and these independent variables. In addition, the association between a patient's prognosis and these factors will also be analyzed. ROC curve will be used to compare our regression model to the established GCS score scale and Marshall CT grading.

Connect with a study center

  • Shanghai 6th People's Hospital

    Shanghai, 200233
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.