Clinical Significance of circMETTL9 Gene in Traumatic Brain Injury

NCT05484921 | Unknown

• 1 other identifier: 2022-L129
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

TBI (Traumatic Brain Injury)

Keywords

traumatic brain injury; circMETTL9

Outcome Measures

Primary Outcomes (1)

• The sensitivity and specificity of circMETTL9 in TBI patients were analyzed.

  rComparison of serum cirMETTL9 expression levels among the three groups. The results of qRT-PCR showed that, compared with the healthy control group, the serum cirMETTL9 expression levels in the moderate TBI group and the severe TBI group were significantly increased, and the serum cirMETTL9 expression level in the severe TBI group was significantly higher than that in the patients with severe TBI. In the moderate TBI group, the difference was statistically significant (P \< 0.05).

  2022-01-2023-12

Secondary Outcomes (1)

• The correlation of circMETTL9 in blood samples of TBI patients with disturbance of consciousness and cognitive function in TBI patients was analyzed.

  2022-01-2023-12

Other Outcomes (1)

• The correlation between circMETTL9 and prognosis in blood samples of TBI patients was analyzed.

  2022-01-2023-12

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

TBI patients

You may qualify if:

• Age from 18 to 80 years old, gender is not limited;
• Have a clear history of TBI and be diagnosed by head CT, and it is the first episode;
• Glasgow Coma Scale (GCS) score less than or equal to 12;
• The condition is relatively stable, and there is no serious chronic disease;
• Obtain informed consent from patients and (or) their families.

You may not qualify if:

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

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

Study Sites (1)

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

liu su, PhD

CONTACT

13814701181; 327202278@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2022
• First Posted: August 2, 2022
• Study Start: August 4, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: August 5, 2022

Record last verified: 2022-04

Locations

CN (1)