Identifying biomarkers for diagnosing mild to moderate traumatic brain injury
Rapid Diagnosis and Prognosis Recognition of Imaging and Biomarkers in Mild to Moderate Traumatic Brain Injury
This study is trying to find better ways to diagnose mild to moderate brain injuries in people by testing different imaging techniques and blood markers to see if they can help doctors make more accurate decisions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital Xi'an Jiaotong University Academic / other |
| Locations | 1 site (Xi'an, Shaanxi) |
| Trial ID | NCT05108909 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify optimal diagnostic and prognostic biomarkers for mild to moderate traumatic brain injury (MTBI) within the Chinese population. By analyzing multi-center data, the researchers will evaluate the effectiveness of imaging techniques like MRI and CT, alongside serum biomarkers, to improve diagnosis and reduce unnecessary imaging procedures. The study will focus on establishing critical cutoff values for these biomarkers to enhance clinical decision-making regarding TBI. The findings are expected to provide a substantial basis for better clinical diagnosis and prognosis recognition in TBI patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-75 with a Glasgow Coma Scale score of 9-15 who have experienced a non-penetrating TBI within one week of onset.
Not a fit: Patients with acute suspected stroke, neurodegenerative diseases, or contraindications to MRI scanning will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and efficient diagnosis of mild to moderate traumatic brain injuries, potentially reducing unnecessary imaging and improving patient outcomes.
How similar studies have performed: Previous studies in European and American populations have shown promise in using biomarkers for TBI diagnosis, but this approach is novel for the Chinese population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age 18-75 years at time of recruitment. * Glasgow Coma Scale (GCS) score of 9-15 at the time of informed consent. * non-penetrating TBI resulting from an external force. * diagnosed within 1 week after onset of TBI. * provision of informed written consent. Exclusion Criteria: * acute suspected stroke, neurosurgery, stroke or TIA within the last 30 days. * neurodegenerative disease or other neurological disorder including dementia, Parkinson's disease, multiple sclerosis, seizure disorder, brain tumors. * a history of a previous brain injury, or a history of concurrent substance or alcohol abuse; * the manifestation of TBI caused by medications, alcohol, drugs for other injuries (such as systemic injuries, facial injuries, or intubation). * pregnancy or breastfeeding. * Patients with contraindications to MRI scanning (such as patients with metal implants in their bodies, cardiac pacemakers, dentures, etc.) * participation in a clinical research study with potential to affect the results of this study
Where this trial is running
Xi'an, Shaanxi
- First Affiliated Hospital of Xian Jiaotong University — Xi'an, Shaanxi, China (Recruiting)
Study contacts
- Principal investigator: Ming Zhang, phD — First Affiliated Hospital of Xian Jiaotong University
- Study coordinator: Ming Zhang, phD
- Email: zmmri@163.com
- Phone: 0086-18991232265
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.