NCT06131242

The s100β Levels in Patients With Mild Brain Injury.

The Application Value of Serum S100β in Acute Mild Traumatic Brain Injury.

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 494 (estimated)
• Sponsor: Sumei Lu · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Mild traumatic brain injury (TBI) accounts for the majority of TBI. At present, whether TBI has traumatic intracranial lession is mainly diagnosed by computed tomography (CT), while only 5% of mild TBI has positive CT results. The risk stratification method for patients with mild TBI is needed to reduce unnecessary CT use and reduce medical costs. S100β is a protein in glial cells and can be used as a biomarker of brain injury. S100β is showed to have the clinical and economic value in ruling out traumatic intracranial lesions in mild TBI patients in Europe and the United States. However, it was showed to have difference between races, and there lacks systematic research data from Chinese population. In addition, if it is used for emergency departments, it is necessary to evaluate new rapid detection methods. This study is based on a novel fast S100β test. The reference intervals of S100β in Chinese adults will be established. Further, evaluation of S100β in diagnosis of traumatic intracranial lesions in acute mild TBI will be conducted from the perspective of clinical and economic value in China, which will provide data for screening of low-risk TBI patients and avoiding unnecessary CT use in clinical practice.

Conditions

• Brain Concussion

Interventions

Type	Name	Description
OTHER	It is an observational study	It is an observational study

Timeline

• Start date: 2023-11-09
• Primary completion: 2026-04-30
• Completion: 2026-08-31
• First posted: 2023-11-14
• Last updated: 2023-11-18