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

MTBI - Mild Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05108909
• Other study ID #: 82071993-2
• Status: Recruiting
• Start date: September 1, 2021
• Est. completion date: August 31, 2025

Study information

• Verified date: October 2021
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Ming Zhang, phD
• Phone: 0086-18991232265
• Email: zmmri[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Moderate Traumatic Brain Injury
• MTBI - Mild Traumatic Brain Injury
• Wounds and Injuries

Intervention

Device:
• MRI, CT, and serum biomarkers
magnetic resonance image Imaging data were collected in a strong magnetic field, and collected the serum of participants.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xian Jiaotong University	Xi'an	Shaanxi

Sponsors (5)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University	Central South University, School of Life Science and Technology, Xi'an Jiaotong University, Second Affiliated Hospital of Wenzhou Medical University, Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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-1ß with pg/mL, TNF-a 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.
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.