Rapid Diagnosis and Prognosis Recognition of Imaging and Biomarkers in Mild to Moderate Traumatic Brain Injury

Xi'an Jiaotong University

Status: Enrolling

Conditions: Moderate Traumatic Brain Injury; MTBI - Mild Traumatic Brain Injury

Treatments: Device: MRI, CT, and serum biomarkers

Study type: Observational

Funder types: Other

Identifiers

NCT05108909

82071993-2

Details and patient eligibility

About

The investigators will carry out multi-center and large sample research based on the Chinese population, screen the optimal diagnostic and prognosis recognition biomarkers and analyze the diagnostic critical cutoff values in patients with mild to moderate traumatic brain injury, so as to provide a substantial basis for clinical diagnosis and prognosis recognition.

Full description

Traumatic brain injury (TBI) is a complex disorder that comprises a spectrum of intracranial pathologies, many of which present diagnostic challenges. Detection of intracranial injuries after TBI relies on head CT, which is overused and resource intensive. Prior studies have shown the potential for blood-based brain injury biomarkers to predict the absence of intracranial injury after TBI and aid in reducing unnecessary head CT use. Furthermore, plasma biomarker concentrations in the acute phase after TBI identified patients with a suspected TBI and normal head CT who had detectable pathology on MRI. However, most of the current studies are based on the European and American population, and whether the research results are applicable to the Chinese population remains to be studied. Therefore, the investigators will carry out multi-center and large sample research based on the Chinese population, screen the optimal diagnostic and prognosis recognition biomarkers and analyze the diagnostic critical cutoff values, so as to provide a substantial basis for clinical diagnosis and prognosis recognition.

Enrollment: 800 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

800 participants in 3 patient groups

mild to moderate traumatic brain injury

Description:

patients diagnosed with mild to moderate traumatic brain injury within 1 week after onset of TBI.

Treatment:

Device: MRI, CT, and serum biomarkers

isolated orthopaedic trauma patients

Description:

Patients with isolated orthopaedic trauma were identified and enrolled using the same process as that for patients with TBI.

Treatment:

Device: MRI, CT, and serum biomarkers

healthy non-injury control

Description:

Healthy non-injured controls were recruited either via a relationship with a TRACK-TBI participant or through public advertisement within TRACK-TBI institutions, and were able to provide informed consent.

Treatment:

Device: MRI, CT, and serum biomarkers