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

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.

Study Overview

• Status: Recruiting
• Conditions: MTBI - Mild Traumatic Brain Injury; Moderate Traumatic Brain Injury
• Intervention / Treatment: Device: MRI, CT, and serum biomarkers

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 Type: Observational
• Enrollment (Anticipated): 800

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • Recruiting
      • First Affiliated Hospital of Xian Jiaotong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

TBI patients will be recruited from the emergency department of hospital.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
mild to moderate traumatic brain injury; patients diagnosed with mild to moderate traumatic brain injury within 1 week after onset of TBI.	Device: MRI, CT, and serum biomarkers; magnetic resonance image Imaging data were collected in a strong magnetic field, and collected the serum of participants.
isolated orthopaedic trauma patients; Patients with isolated orthopaedic trauma were identified and enrolled using the same process as that for patients with TBI.	Device: MRI, CT, and serum biomarkers; magnetic resonance image Imaging data were collected in a strong magnetic field, and collected the serum of participants.
healthy non-injury control; 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.	Device: MRI, CT, and serum biomarkers; magnetic resonance image Imaging data were collected in a strong magnetic field, and collected the serum of participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The concentration of serum biomarkers.	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;	baseline (early injury), post-traumatic for 3 months, 6 months, and 12 months.
Score of Extended Glasgow Outcome Scale.	The functional outcome of TBI patients. The minimum value is 1, and the maximum value is 8. The higher scores mean a better outcome.	post-traumatic for 3 months
Score of Extended Glasgow Outcome Scale.	The functional outcome of TBI patients. The minimum value is 1, and the maximum value is 8. The higher scores mean a better outcome.	post-traumatic for 6 months
Score of Extended Glasgow Outcome Scale.	The functional outcome of TBI patients. The minimum value is 1, and the maximum value is 8. The higher scores mean a better outcome.	post-traumatic for 12 months
Number of participants with positive head CT scan	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.	baseline (early injury)
Number of participants with MRI abnormalities	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).	baseline (early injury)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline brain structure measures at 3 months	The changes of brain volume (mm3) are evaluated by structural MRI	baseline (early injury), post-traumatic for 3 months.
Change from baseline brain structure measures at 6 months	The changes of brain volume (mm3) are evaluated by structural MRI	baseline (early injury), post-traumatic for 6 months.
Change from baseline brain structure measures at 12 months	The changes of brain volume (mm3) are evaluated by structural MRI	baseline (early injury), post-traumatic for 12 months.
White matter integrity at 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.	baseline (early injury), post-traumatic for 3 months,6 months, and 12 months.

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Collaborators: Xijing Hospital; Second Affiliated Hospital of Wenzhou Medical University; Central South University; School of Life Science and Technology, Xi'an Jiaotong University
• Investigators: Principal Investigator: Ming Zhang, PhD, First Affiliated Hospital of Xian Jiaotong University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Anticipated): August 31, 2025
• Study Completion (Anticipated): August 31, 2025

Study Registration Dates

• First Submitted: September 24, 2021
• First Submitted That Met QC Criteria: November 3, 2021
• First Posted (Actual): November 5, 2021

Study Record Updates

• Last Update Posted (Actual): January 4, 2022
• Last Update Submitted That Met QC Criteria: January 3, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: biomarkers; CT; diagnosis; mild to moderate traumatic brain injury; magnetic resonance image; Prognostic identification
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: 82071993-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No