Clinical Significance of circMETTL9 Gene in Traumatic Brain Injury

NCT ID: NCT05484921

Last Updated: 2022-08-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-04
• Study Completion Date: 2023-12-30

Brief Summary

Objective: The relevance of circMETTL9 to the degree of injury, disturbance of consciousness, cognitive function and prognosis in patients with moderate to severe traumatic brain injury (TBI) remains unknown. The purpose of this study was to investigate the effect of circMETTL9 on the degree of injury, disturbance of consciousness, cognitive function and prognosis after TBI.

Detailed Description

1. Collect blood samples from patients with moderate to severe TBI and healthy people, and detect the expression of circMETTL9 by Real-time Quantitative PCR Detecting System(qPCR).Receiver operating characteristic curve (ROC) was used to analyze the sensitivity and specificity of circMETTL9 in TBI patients.

2. Using the Glasgow coma scale (GCS) and the coma recovery scale-revised (CRS-R) to assess the patient's disturbance of consciousness at 1, 3, 7, 14, and 21 days after TBI, respectively, The cognitive function of patients was assessed with the revised Rachel los amigos scale-revised (RLAS-R), and the correlation of circMETTL9 with disturbance of consciousness and cognitive function in TBI patients was analyzed.

3. Six months after TBI, the disability rating scale (DRS) and Glasgow outcome scale-extended (GOSE) were used to evaluate the prognosis of patients six months after discharge, and the correlation between circMETTL9 and prognosis was analyzed. sex.

Conditions

TBI (Traumatic Brain Injury)

Study Design

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

Study Groups

traumatic brain injury group

(1) age 18-80 years, (2) admission due to isolated head injury, (3) unconsciousness at the time of injury. Isolated head trauma was defined as CT scan-confirmed brain injury without other major extracranial injuries, such as pelvis fractures, femur fractures, and severe invasive abdominal or thoracic injuries. Other exclusion criteria for patients were infection within the most recent month, previous head trauma, neurological diseases including ischemic and hemorrhagic stroke, use of antiplatelet or anticoagulant medications, and other prior systemic diseases including uremia, liver cirrhosis, malignancy, chronic heart disease, and chronic lung disease.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Age from 18 to 80 years old, gender is not limited;

2. Have a clear history of TBI and be diagnosed by head CT, and it is the first episode;

3. Glasgow Coma Scale (GCS) score less than or equal to 12;

4. The condition is relatively stable, and there is no serious chronic disease;

5. Obtain informed consent from patients and (or) their families.

Exclusion Criteria

1 Combined with severe underlying diseases such as respiratory failure, heart failure, liver and kidney insufficiency; previous stroke, intracranial tumor, intracranial infection, dementia, Alzheimer's disease, Parkinson's disease, endocrine disease, immune and blood system diseases.

2. Patients with pelvic fractures, substantial organ damage, etc., which may seriously affect the treatment effect at the time of injury;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Affiliated Hospital of Nantong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

liu su, PhD

Role: CONTACT

327202278@qq.com

13814701181

Facility Contacts

Su Liu

Role: primary

Other Identifiers

2022-L129

Identifier Type: -

Identifier Source: org_study_id