Collecting and analyzing clinical and molecular data in patients with traumatic brain injury
Official title: Clinical and Molecular Biological Data Collection and Analysis in Patients With Traumatic Brain Injury (TBI)
Run by Shanghai 6th People's Hospital · NCT05533060 · Data updated 2026-11-12
This study is testing if collecting detailed health information and brain tissue samples from patients with traumatic brain injury can help doctors better predict recovery and outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Shanghai 6th People's Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Status | Recruiting |
| Started | September 1, 2022 |
| Main results expected | December 30, 2027 |
| Study ends | December 30, 2027 |
| Registry record updated | May 6, 2025 |
| Trial ID | NCT05533060 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with CT/MRI confirmed TBI who are within 12 hours of injury and meet specific clinical criteria.
✕Probably not a fit
Patients who are not suitable for surgery or have severe pre-existing conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to improve the evaluation and prognosis prediction of patients with traumatic brain injury (TBI) by collecting and analyzing clinical data alongside molecular biomarkers obtained through single-cell sequencing. Eligible patients will undergo surgical treatment, during which brain tissue will be preserved for further analysis. The study will utilize high-throughput sequencing and bioinformatics to identify significant biomarkers and compare them with existing evaluation methods. The goal is to develop a regression model that correlates neurological status with various clinical factors, enhancing the accuracy of patient outcome predictions.
Why it matters
Potential benefit: If successful, this study could lead to more accurate assessments and better prognostic predictions for patients with traumatic brain injury.
How similar studies have gone: While there have been studies focusing on molecular biomarkers in TBI, this specific approach combining clinical data with single-cell sequencing is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Shanghai 6th People's Hospital
Shanghai, China Recruiting
Study contacts
- Study coordinator: Yang Yang, MD, PhD
- Email: yang.cne.yang@gmail.com
- Phone: 18210391762
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.