Clinical trial NCT05484921: Clinical Significance of circMETTL9 Gene in Traumatic Brain Injury
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: TBI (Traumatic Brain Injury)
Keywords: traumatic brain injury
circMETTL9
Lead sponsor: Affiliated Hospital of Nantong University
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: TBI patients

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.

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;

Primary outcomes:
measure: The sensitivity and specificity of circMETTL9 in TBI patients were analyzed.
timeFrame: 2022-01-2023-12
Secondary outcomes:
measure: The correlation of circMETTL9 in blood samples of TBI patients with disturbance of consciousness and cognitive function in TBI patients was analyzed.
timeFrame: 2022-01-2023-12
Other outcomes:
measure: The correlation between circMETTL9 and prognosis in blood samples of TBI patients was analyzed.
timeFrame: 2022-01-2023-12
Locations:
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangsu
Study officials:
References: