Analyzing blood samples to identify biomarkers in traumatic brain injury
Proteomic and Metabolomic Detection and Analysis of Serum from Patients with Acute Severe Traumatic Brain Injury: a Prospective, Multicentered Study
This study is testing blood samples from patients with traumatic brain injuries to see if they have different markers compared to those with bone fractures, which could help doctors diagnose brain injuries better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | RenJi Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT05867992 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify biomarkers in the serum of patients with acute traumatic brain injury (TBI) by comparing them to patients with traumatic bone fractures. Blood samples will be collected from eligible patients in the emergency room and analyzed for proteins and metabolites that are differently expressed in TBI cases. The goal is to discover potential new serum biomarkers that could aid in the diagnosis of TBI. The study will utilize proteomic and metabolomic detection methods to analyze the collected samples.
Who should consider this trial
Good fit: Ideal candidates include patients with cerebral contusions or traumatic bone fractures who present within 24 hours of injury.
Not a fit: Patients with pre-existing neurological conditions or those who have sustained a bone fracture in the case group will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the development of new diagnostic biomarkers for traumatic brain injury, improving patient outcomes.
How similar studies have performed: Other studies have shown promise in identifying biomarkers for TBI, but this specific multiomic approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * With cerebral contusion in 24Hrs for case group, or with traumatic bone fracture in 24Hrs for control group. * The Glasglow Coma Scale ranges in 3-8 for case group. * Need to have routine laboratory examination of blood sample. * Patients or agents sign the informed consent. Exclusion Criteria: * With bone fracture for case group, or with brain injury for control group. * Have Orthopaedic history for case group, or have Neurological history for control group. * Death in 24 hours. * Immunosuppressed state. * Severe multiple organ dysfunction. * With infection. * Pregnant.
Where this trial is running
Shanghai, Shanghai
- Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Junfeng Feng, Ph.D. — RenJi Hospital
- Study coordinator: Zhenghui He, M.D.
- Email: hezhenghui8@qq.com
- Phone: +8613585916217
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.