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

Recruiting

• Conditions: MTBI - Mild Traumatic Brain Injury; Moderate Traumatic Brain Injury
• Interventions: Device: MRI, CT, and serum biomarkers

• Registration Number: NCT05108909
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2021-09-24
• Status Verified: 2021-10
• Study First Submitted QC: 2021-11-03
• Study First Posted: 2021-11-05
• Last Update Submitted: 2022-01-03
• Last Update Posted: 2022-01-04
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
mild to moderate traumatic brain injury	MRI, CT, and serum biomarkers	patients diagnosed with mild to moderate traumatic brain injury within 1 week after onset of TBI.
isolated orthopaedic trauma patients	MRI, CT, and serum biomarkers	Patients with isolated orthopaedic trauma were identified and enrolled using the same process as that for patients with TBI.
healthy non-injury control	MRI, CT, and serum biomarkers	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.

Primary Outcome Measures

Name	Time	Method
The concentration of serum biomarkers.	baseline (early injury), post-traumatic for 3 months, 6 months, and 12 months.	the concentration of GFAP with pg/mL, S-100B with pg/mL，IL-6 with pg/mL, IL-8 with pg/mL, IL-10 with pg/mL, IL-1β with pg/mL, TNF-α with pg/mL, UCH-L1 with pg/mL, NSE with pg/mL, T-Tau with pg/mL, P-Tau with pg/mL, NFL with pg/mL, BDNF with pg/mL, and VEGF with pg/mL;
Score of Extended Glasgow Outcome Scale.	post-traumatic for 12 months	The functional outcome of TBI patients. The minimum value is 1, and the maximum value is 8. The higher scores mean a better outcome.
Number of participants with positive head CT scan	baseline (early injury)	CT-positive was defined as the presence of one or more of the following injuries: acute epidural haematoma, acute subdural haematoma, indeterminate extraaxial haemorrhage, intraventricular haemorrhage, parenchymal haematoma, petechial haemorrhagic or bland sheer injury, subarachnoid haemorrhage, brain oedema, brain herniation, non-haemorrhagic contusion, ventricular compression, ventricular trapping, cranial fractures, depressed skull fractures, facial fractures, scalp injury, or skull base fractures.
Number of participants with MRI abnormalities	baseline (early injury)	MRI abnormalities were quantified according to common data elements standards and definitions by three board-certified neuroradiologists masked to the identity and clinical history of the patient. MRI scans were read as positive if there was evidence of acute intracranial pathology consistent with TBI (eg, contusion, traumatic axonal injury, diffuse axonal injury).

Secondary Outcome Measures

Name	Time	Method
Change from baseline brain structure measures at 3 months	baseline (early injury), post-traumatic for 3 months.	The changes of brain volume (mm3) are evaluated by structural MRI
Change from baseline brain structure measures at 6 months	baseline (early injury), post-traumatic for 6 months.	The changes of brain volume (mm3) are evaluated by structural MRI
Change from baseline brain structure measures at 12 months	baseline (early injury), post-traumatic for 12 months.	The changes of brain volume (mm3) are evaluated by structural MRI
White matter integrity at baseline (early injury), post-traumatic for 3 months,6 months, and 12 months.	baseline (early injury), post-traumatic for 3 months,6 months, and 12 months.	The white matter integrity are characterized by fractional anisotropy (FA) which calculated by diffusion tensor imaging.

Trial Locations

Locations (1)

First Affiliated Hospital of Xian Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China