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

NCT05108909 | Unknown

• 1 other identifier: 82071993-2
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

MTBI - Mild Traumatic Brain Injury; Moderate Traumatic Brain Injury

Keywords

mild to moderate traumatic brain injury; biomarkers; magnetic resonance image; CT; diagnosis; Prognostic identification

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• Change from baseline brain structure measures at 3 months

  baseline (early injury), post-traumatic for 3 months.

• Change from baseline brain structure measures at 6 months

  baseline (early injury), post-traumatic for 6 months.

• Change from baseline brain structure measures at 12 months

  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.

  baseline (early injury), post-traumatic for 3 months,6 months, and 12 months.

Study Arms (3)

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

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

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

Interventions

MRI, CT, and serum biomarkers DEVICE

magnetic resonance image Imaging data were collected in a strong magnetic field, and collected the serum of participants.

healthy non-injury control; isolated orthopaedic trauma patients; mild to moderate traumatic brain injury

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• Xi'an Jiaotong University: collaborator
• Second Affiliated Hospital of Wenzhou Medical University: collaborator
• Central South University: collaborator
• Xijing Hospital: collaborator

Study Sites (1)

First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, gut microbiota, urine

MeSH Terms

Conditions

Brain Concussion; Disease

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ming Zhang, phD

  First Affiliated Hospital of Xian Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Zhang, phD

CONTACT

0086-18991232265; zmmri@163.com

Lijun Bai, phD

CONTACT

0086-15129034948; bailijun@xjtu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: November 5, 2021
• Study Start: September 1, 2021
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: January 4, 2022

Record last verified: 2021-10

Locations

CN (1)