TBI (Traumatic Brain Injury)NCT05484921
Clinical Significance of circMETTL9 Gene in Traumatic Brain Injury
An observational study of TBI (Traumatic Brain Injury), run by Affiliated Hospital of Nantong University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- TBI (Traumatic Brain Injury)
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 4 Aug 2022to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: TBI patients
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of Nantong University
Nantong, Jiangsu
Su Liu
About this study
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
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.
Read the detailed description
- 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.
- 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.
- 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)
- Keywords
- traumatic brain injury, circMETTL9
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
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.
Measured: 2022-01-2023-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start4 Aug 2022 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TBI (Traumatic Brain Injury)Studies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05484921
- Sponsor's protocol ID
- 2022-L129
- Status last verified
- Apr 2022
- First submitted
- 31 Jul 2022
- Last updated
- 5 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05484921
- Acronym / sponsor ID
- 2022-L129
- Conditions
- TBI (Traumatic Brain Injury)
- Keywords
- traumatic brain injury, circMETTL9
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 4 Aug 2022 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 2 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- TBI patients
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The sensitivity and specificity of circMETTL9 in TBI patients were analyzed.
Time frame: 2022-01-2023-12
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).
1 secondary outcome
The correlation of circMETTL9 in blood samples of TBI patients with disturbance of consciousness and cognitive function in TBI patients was analyzed.
Time frame: 2022-01-2023-12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of TBI (Traumatic Brain Injury), run by Affiliated Hospital of Nantong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact liu su, PhD (13814701181, 327202278@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sensitivity and specificity of circMETTL9 in TBI patients were analyzed. (time frame: 2022-01-2023-12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.