Multiomic Analysis of Serum in Acute Period of Traumatic Brain Injury (MASTER-TBI)

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Traumatic Brain Injury

Treatments: Other: Type of trauma

Study type: Observational

Funder types: Other

Identifiers

NCT05867992

LY2024-006

Details and patient eligibility

About

The goal of this experimental observation study is to figure out differently expressed biomarkers in serum in traumatic brain injury patients, compared with bone fracture patients. The main questions it aims to answer are:

1. Which proteins and metabolites are differently expressed in TBI patients' serum?
2. Which proteins or metabolites can serve as the new serum biomarkers for diagnosing TBI? Participants will be treated by routine treatments, and their serum samples will be collected in the emergency room.

Full description

This experimental observation study is designed to find out some new characteristics in acute severe traumatic brain injury. To filter the stress response in blood, patients with traumatic fracture are chosen as the control group.

Blood samples of patients who pass the eligibility criteria will be collected immediately in the emergency room. Then the samples will be preprocessed in the laboratory to get serums. These collected serums will be preserved in -80℃ until completing all sample collection. After completing collection, all samples will be sent to proteomic and metabolomic detection. The bioinformatic data will be analyzed to answer these main questions:

1. Which proteins and metabolites are differently expressed in TBI patients' serum? (As a whole characteristic of acute severe TBI)
2. Which proteins or metabolites can serve as the new serum biomarkers for diagnosing TBI? (Deeply digging the value of characteristic of acute severe TBI)

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• With cerebral contusion in 24Hrs for case group, or with traumatic bone fracture in 24Hrs for control group.
• The Glasglow Coma Scale ranges in 3-8 for case group.
• Need to have routine laboratory examination of blood sample.
• Patients or agents sign the informed consent.

Exclusion criteria

• With bone fracture for case group, or with brain injury for control group.
• Have Orthopaedic history for case group, or have Neurological history for control group.
• Death in 24 hours.
• Immunosuppressed state.
• Severe multiple organ dysfunction.
• With infection.
• Pregnant.

Trial design

80 participants in 2 patient groups

Case group

Description:

This group enrolls patients with acute severe traumatic brain injury.

Treatment:

Other: Type of trauma

Control group

Description:

This group enrolls patients with acute traumatic bone fracture but without traumatic brain injury.

Treatment:

Other: Type of trauma