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

Recruiting now

Conditions studied: Traumatic Brain Injury

In brief

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.

Key facts

Study ID

NCT05533060

Run by

Shanghai 6th People's Hospital

People needed

200

Starts

2022-09-01

Expected to finish

2027-12-30

Last updated by the study team

2025-05-06

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Shanghai 6th People's Hospital — Shanghai, China (enrolling)

Full record on ClinicalTrials.gov

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