Clinical Significance of circMETTL9 Gene in Traumatic Brain Injury

TBI (Traumatic Brain Injury) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05484921
• Other study ID #: 2022-L129
• Status: Recruiting
• Start date: August 4, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: April 2022
• Source: Affiliated Hospital of Nantong University
• Contact: liu su, PhD
• Phone: 13814701181
• Email: 327202278[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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;

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• TBI (Traumatic Brain Injury)
• Wounds and Injuries

Locations

Country	Name	City	State
China	Affiliated Hospital of Nantong University	Nantong	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital of Nantong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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