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Recruiting Observational

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

NCT05533060 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2022-09-01
Last updated
2025-05-06

Condition(s) studied

Traumatic Brain Injury

Investigational drug(s) / intervention(s)

No intervention

No intervention: patients in the groups are treated surgically and brain tissue, CSF, and blood samples, as well as clinical data, neuroimaging data are collected

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

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Accurate assessment of patients' neurological condition — 2022.09-2023.12
    Using a regression model to explore the relationship between a patient's neurological condition and clinical and molecular biological data

Trial sites (1)

FacilityCityRegionStatus
Shanghai 6th People's Hospital Shanghai China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05533060 on ClinicalTrials.gov ↗ ← All trials in China