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NCT Number: NCT05533060

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai 6th People's Hospital

Shanghai, 200233, China

Location status: Recruiting

Location contact

Hao Chen, M.D., Ph.D.

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

patients in the groups are treated surgically and brain tissue, CSF, and blood samples, as well as clinical data, neuroimaging data are collected

Primary outcomes

  1. Accurate assessment of patients' neurological condition

    Time frame: 2022.09-2023.12

    Using a regression model to explore the relationship between a patient's neurological condition and clinical and molecular biological data

Secondary outcomes

  1. Predicting patients' outcome accurately

    Time frame: 2022.09-2023.12

    Using a regression model to explore the relationship between a patient's prognosis and clinical and molecular biological data

Study contacts

Contact information is provided by the study sponsor or research team.

Yang Yang, MD, PhD

CONTACT

[email protected]

18210391762

Sponsors and collaborators

Lead sponsor

Shanghai 6th People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Sep 8, 2022
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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