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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorShanghai 6th People's Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

patients with traumatic brain injury (TBI) or other brain diseases (gliomas, meningiomas, schwannoma) who are treated surgically

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • No intervention

    Other intervention

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

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: TBI group1 intervention
Group B: RN group1 intervention

Trial outcomes

Primary outcomes

1

Accurate assessment of patients' neurological condition

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

Time frame
2022.09-2023.12

Secondary outcomes

1

Predicting patients' outcome accurately

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

Time frame
2022.09-2023.12

Other outcomes

Sponsors and contacts

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