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

NCT ID: NCT05108909

Last Updated: 2022-01-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2025-08-31

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.

Conditions

MTBI - Mild Traumatic Brain Injury; Moderate Traumatic Brain Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

mild to moderate traumatic brain injury

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

MRI, CT, and serum biomarkers

Intervention Type: DEVICE

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.

MRI, CT, and serum biomarkers

Intervention Type: DEVICE

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.

MRI, CT, and serum biomarkers

Intervention Type: DEVICE

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

Interventions

MRI, CT, and serum biomarkers

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Xi'an Jiaotong University

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role: collaborator

Central South University

OTHER

Sponsor Role: collaborator

Xijing Hospital

OTHER

Sponsor Role: collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ming Zhang, phD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Xian Jiaotong University

Locations

First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ming Zhang, phD

Role: CONTACT

zmmri@163.com

0086-18991232265

Lijun Bai, phD

Role: CONTACT

bailijun@xjtu.edu.cn

0086-15129034948

Facility Contacts

Ming Zhang, phD

Role: primary

zmmri@163.com

0086-18991232265

Lijun Bai, phD

Role: backup

bailijun@xjtu.edu.cn

0086-15129034948

Other Identifiers

82071993-2

Identifier Type: -

Identifier Source: org_study_id