Collecting and analyzing clinical and molecular data in patients with traumatic brain injury

Clinical and Molecular Biological Data Collection and Analysis in Patients With Traumatic Brain Injury (TBI)

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
• Enrollment: 200 (estimated)
• Sex: All
• Sponsor: Shanghai 6th People's Hospital (Academic / other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT05533060 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include patients with CT/MRI confirmed TBI who are within 12 hours of injury and meet specific clinical criteria.

Not a fit: Patients who are not suitable for surgery or have severe pre-existing conditions may not benefit from this study.

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 performed: While there have been studies focusing on molecular biomarkers in TBI, this specific approach combining clinical data with single-cell sequencing is relatively novel.

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.

Where this trial is running

Shanghai

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

Study contacts

• Study coordinator: Yang Yang, MD, PhD

Conditions Traumatic Brain Injury; Traumatic brain injury; Molecular biomarkers; Single-cell sequencing; High-throughput sequencing