Clinical Significance of circMETTL9 Gene in Traumatic Brain Injury

The Specificity and Sensitivity of circMETTL9 Gene in Patients With Traumatic Brain Injury, Its Correlation With Cognitive Function and Disturbance of Consciousness, and Prognosis

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.

Study Overview

• Status: Recruiting
• Conditions: TBI (Traumatic Brain Injury)

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.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: liu su, PhD; Phone Number: 13814701181; Email: 327202278@qq.com

Study Locations

• China
  • Jiangsu
    • Nantong, Jiangsu, China
      • Recruiting
      • Affiliated Hospital Of Nantong University
      • Contact: Su Liu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

TBI patients

Description

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;

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The correlation of circMETTL9 in blood samples of TBI patients with disturbance of consciousness and cognitive function in TBI patients was analyzed.	Blood samples were collected from patients with moderate to severe TBI and healthy individuals, and the expression of circMETTL9 was detected by qPCR. Receiver operating characteristic curve (ROC) was used to analyze the sensitivity and specificity of circMETTL9 in TBI patients.	2022-01-2023-12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The correlation between circMETTL9 and prognosis in blood samples of TBI patients was analyzed.	Six months after TBI, 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.	2022-01-2023-12

Collaborators and Investigators

• Sponsor: Affiliated Hospital of Nantong University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 4, 2022
• Primary Completion (Anticipated): December 30, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: July 31, 2022
• First Submitted That Met QC Criteria: July 31, 2022
• First Posted (Actual): August 2, 2022

Study Record Updates

• Last Update Posted (Actual): August 5, 2022
• Last Update Submitted That Met QC Criteria: August 3, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: traumatic brain injury; circMETTL9
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: 2022-L129

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No