UnknownNot Applicable

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

China800 participantsStarted 2021-09-01

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The concentration of serum biomarkers.

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

Score of Extended Glasgow Outcome Scale.

Timeframe: post-traumatic for 3 months

Score of Extended Glasgow Outcome Scale.

Timeframe: post-traumatic for 6 months

Score of Extended Glasgow Outcome Scale.

Timeframe: post-traumatic for 12 months

Number of participants with positive head CT scan

Timeframe: baseline (early injury)

Number of participants with MRI abnormalities

Timeframe: baseline (early injury)

Trial details

NCT IDNCT05108909

SponsorFirst Affiliated Hospital Xi'an Jiaotong University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-08-31

Contact for this trial

Ming Zhang, phD

0086-18991232265 zmmri@163.com

View on ClinicalTrials.gov More MTBI - Mild Traumatic Brain Injury trials

Plain-language summary

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

The concentration of serum biomarkers.

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

Score of Extended Glasgow Outcome Scale.

Timeframe: post-traumatic for 3 months

Score of Extended Glasgow Outcome Scale.

Timeframe: post-traumatic for 6 months

Score of Extended Glasgow Outcome Scale.

Timeframe: post-traumatic for 12 months

Number of participants with positive head CT scan

Timeframe: baseline (early injury)

Number of participants with MRI abnormalities

Timeframe: baseline (early injury)