NCT05533060 Clinical and Molecular Biological Data Collection and Analysis in Patients With TBI
| NCT ID | NCT05533060 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai 6th People's Hospital |
| Condition | Traumatic Brain Injury |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2022-09-01 |
| Primary Completion | 2027-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2022-09-01 with a primary completion date of 2027-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Hengli Tian, MD, PhD
STUDY DIRECTOR
Shanghai 6th People's Hospital
Frequently Asked Questions
Who can join the NCT05533060 clinical trial?
This trial is open to participants of all sexes, studying Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05533060 currently recruiting?
Yes, NCT05533060 is actively recruiting participants. Contact the research team at yang.cne.yang@gmail.com for enrollment information.
Where is the NCT05533060 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT05533060 clinical trial?
NCT05533060 is sponsored by Shanghai 6th People's Hospital. The principal investigator is Hengli Tian, MD, PhD at Shanghai 6th People's Hospital. The trial plans to enroll 200 participants.