Traumatic Brain InjuryNCT06429774
Comparative Effectiveness of Intervention in Multi-level Hospitals for Acute Traumatic Brain Injury(Metric-TBI)
An observational study of Traumatic Brain Injury, run by Beijing Tiantan Hospital at 64 sites in China.
Trial summary
A prospective, multicenter, observational cohort study is designed to compare the effectiveness of intervention in multi-grade hospitals for acute traumatic brain injury and to optimize clinical outcomes. Read more about this study
- Who is it for?
- Ages 1 year to 89 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Neurological function, Mental State, cognitive function, and life quality assessment and Peripheral blood test
- How many people
- 2,000 participants
- Where
- 64 sitesChina
- Study dates
- 1 Aug 2024to 31 Dec 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 year to 89 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: TBI patients recruited from neurosurgical departments at 50 medical centers in China have apparent clinical symptoms that are confirmed by computed tomography or magnetic resonance imaging.
Who may be able to join
- Patient (1 years to 89 years) presenting with clinical symptoms of traumatic brain injury
- Traumatic brain injury verified on cranial computed tomography or magnetic resonance imaging
- Written informed consent from patients or their next of kin according to the patient's cognitive status
Who cannot join
- patients ≥90 years of age
- patients who did not accept follow-up visits or were unable to complete follow-up assessments
- patients with incomplete information
- patients who did not obtain written informed consent
- patients with concomitant cancer or other serious illnesses
Trial locations and contacts
64 sites in 1 country. Contact the study team or a site near you to ask about taking part.
64 sites in 1 country
China64 sites, 64 recruiting
- Not yet recruiting
Affiliated Hospital Of Hebei University
Baoding, Hebei, 071000
- Not yet recruiting
The No.2 Hospital of Baoding
Baoding, Hebei, 071000
- Not yet recruiting
Anguo Hospital
Baoding, Hebei, 071200
- Not yet recruiting
Rongcheng People's Hospital
Baoding, Hebei, 071799
- Not yet recruiting
Xiongxian Hospital
Baoding, Hebei, 071800
- Not yet recruiting
Baoding Seventh Hospital
Baoding, Hebei, 072150
- Recruiting
Gaobeidian Hospital
Baoding, Hebei, 074099
- Not yet recruiting
Yixian Hospital
Baoding, Hebei, 074299
- Not yet recruiting
Beijing Fengtai You'anmen Hospital
Beijing, Beijing Municipality, 100000
- Not yet recruiting
Beijing Huairou Hospital
Beijing, Beijing Municipality, 100000
- Not yet recruiting
Beijing Luhe Hospital,Capital Medical University
Beijing, Beijing Municipality, 100000
- Not yet recruiting
Beijing Red Cross Emergency Medical Center
Beijing, Beijing Municipality, 100000
- Recruiting
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 100000
- Not yet recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100000
- Not yet recruiting
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100020
- Not yet recruiting
Beijing Chaoyang Integrative Medicine Rescue And First Aid Hospital
Beijing, Beijing Municipality, 100020
- Not yet recruiting
Beijing Daxing District People's Hospital
Beijing, Beijing Municipality, 100020
- Not yet recruiting
Peking University International Hospital
Beijing, Beijing Municipality, 100020
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
Weiming Liu, MD, 13701182770 ext. +86, liuweimingnsok@sina.com
Weiming Liu, MD
- Not yet recruiting
Beijing Changping Hospital
Beijing, Beijing Municipality, 102200
- Not yet recruiting
Beijing Mentougou District Hospital
Beijing, Beijing Municipality, 102300
- Not yet recruiting
Liangxiang Hospital
Beijing, Beijing Municipality, 102400
- Not yet recruiting
The First Hospital of Fangshan District, Bejing
Beijing, Beijing Municipality, 102400
- Not yet recruiting
Dongfang Hospital of Beijing University of Chinese Medicine
Beijing, Beijing Municipality, 102401
Gesheng Wang, M.D., +86 13581759316
- Not yet recruiting
Suning Hospital
Cangzhou, Hebei, 062350
- Not yet recruiting
Pingquan Hospital
Chengde, Hebei, 067599
- Not yet recruiting
Luanping Hospital
Chengde, Hebei, 068250
- Not yet recruiting
Hangang Hospital
Handan, Hebei, 056000
- Not yet recruiting
Weixian Chinese Traditional Medicine Hospital
Handan, Hebei, 056800
- Not yet recruiting
The No.1 Hospital Of Yongnian District Handan City
Handan, Hebei, 057150
- Not yet recruiting
Hebei Petro China Central Hospital
Langfang, Hebei, 065000
- Recruiting
Langfang People's Hospital
Langfang, Hebei, 065000
- Not yet recruiting
Edelburg Hospital
Langfang, Hebei, 065099
- Not yet recruiting
Sanhe Hospital
Langfang, Hebei, 065201
- Not yet recruiting
Yanjiao Fuhe No.1 Hospital
Langfang, Hebei, 065201
- Not yet recruiting
Dachang Hui Autonomous County People's Hospital
Langfang, Hebei, 065300
- Not yet recruiting
Xianghe Hospital
Langfang, Hebei, 065400
- Not yet recruiting
Fourth people's Hospital of Langfang
Langfang, Hebei, 065701
- Not yet recruiting
Dacheng Hospital
Langfang, Hebei, 065900
- Not yet recruiting
First Hospital of Qinhuangdao
Qinhuangdao, Hebei, 066199
- Not yet recruiting
Shanhaiguan People's Hospital
Qinhuangdao, Hebei, 066299
- Not yet recruiting
Qinhuangdao Funing District Hospital of Traditional Chinese Medicine
Qinhuangdao, Hebei, 066399
- Not yet recruiting
Lulong Hospital
Qinhuangdao, Hebei, 066499
- Not yet recruiting
Peking University Third Hospital Qinhuangdao Hospital
Qinhuangdao, Hebei, 100083
- Not yet recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
- Not yet recruiting
The Third Hospital Of Shijiazhuang
Shijiazhuang, Hebei, 050000
- Not yet recruiting
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050061
- Not yet recruiting
Jingxing Hospital
Shijiazhuang, Hebei, 050300
- Not yet recruiting
Xinle Chinese Traditional Medicine Hospital
Shijiazhuang, Hebei, 050700
- Not yet recruiting
Tangshan Fengrun People's Hospital
Tangshan, Hebei, 063000
- Not yet recruiting
Tangshan Workers' Hospital
Tangshan, Hebei, 063000
- Not yet recruiting
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, 300000
- Not yet recruiting
Tianjin Hospital
Tianjin, Tianjin Municipality, 300000
- Not yet recruiting
Tianjin Fourth Central Hospital
Tianjin, Tianjin Municipality, 300074
- Not yet recruiting
Tianjin Xiqing Hospital
Tianjin, Tianjin Municipality, 300381
- Not yet recruiting
Wuqing People's Hospital
Tianjin, Tianjin Municipality, 301799
- Not yet recruiting
Xingtai Central Hospital
Xingtai, Hebei, 054000
- Not yet recruiting
Xingtai People's Hospital
Xingtai, Hebei, 054001
- Not yet recruiting
Xingtai Xindu District People's Hospital
Xingtai, Hebei, 054001
- Not yet recruiting
Xingtai Nanhe District People's Hospital
Xingtai, Hebei, 054499
- Not yet recruiting
Pingxiang People's Hospital
Xingtai, Hebei, 054599
- Not yet recruiting
Wei County People's Hospital
Xingtai, Hebei, 054799
- Not yet recruiting
Qinghe Central Hospital
Xingtai, Hebei, 054802
- Not yet recruiting
Xingtai Ninth Hospital
Xingtai, Hebei, 055250
About this study
Official title: Comparative Effectiveness of Intervention in Multi-level Hospitals for Acute Traumatic Brain Injury: a Prospective, Multicenter, Observational Cohort Study
A prospective, multicenter, observational cohort study is designed to compare the effectiveness of intervention in multi-grade hospitals for acute traumatic brain injury and to optimize clinical outcomes.
Read the detailed description
Traumatic brain injury (TBI) is associated with significant morbidity, mortality, and disability, profoundly impacting public health. This study aims to establish a database for acute craniocerebral trauma within the Beijing-Tianjin-Hebei region, and compiles indicators of hospital treatment capabilities and patient data, including neuroimaging, clinical progression, and rehabilitation prognoses.The study is bifurcated into two segments: the initial phase surveys the current status of acute treatment outcomes for TBI inpatients across hospitals in the Beijing-Tianjin-Hebei region and conducts a comparative effectiveness analysis to identify the clinical interventions to optimize. Subsequent phases build on the former by applying optimized treatment strategies to improve efficacy and establish collaborative optimized treatment protocols.
This is a prospective, multicenter, observational study designed to enroll 2,000 patients under the age of 90 years with traumatic brain injury in the presence of clinical symptoms confirmed by computed tomography or magnetic resonance imaging.The primary outcome is the Extended Glasgow Outcome Score within 12 months. Secondary outcomes include the Generalized Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire-9(PHQ-9), Rivermead post-concussion symptoms questionnaire(RPQ), PTSD Checklist-5 Version(PCL-5)，Six-Item Screener (SIS) and 12-Item Short-Form Health Survey version 2(SF-12v2).
The objective of this study is anticipated to the Beijing-Tianjin-Hebei region a 20 percent increase in the number of cases treated by optimized clinical practice guidelines and a 10 percent decrement in mortality and disability rates among TBI patients in the region.
- Conditions
- Traumatic Brain Injury
- Being tested
- Neurological function, Mental State, cognitive function, and life quality assessment, Peripheral blood test, Hematoma test
- Keywords
- Traumatic Brain Injury, Beijing-Tianjin-Hebei region, Database, Comparative effectiveness of intervention, Clinical Treatment Guideline
- 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.
Neurological functionOther
Neurological function will be examined using Glasgow Coma Scale (GCS) and Extended Glasgow Outcome Scale (GOSE).The GOSE was created as an advancement from the original GOS. The GOSE score categorizes the prognosis of patients with traumatic brain injury into eight categories.The 8 categories are: Dead, Vegetative State, Lower Severe Disability, Upper Severe Disability, Lower Moderate Disability, Upper Moderate Disability, Lower Good Recovery, and Upper Good Recovery.
Mental State, cognitive function, and life quality assessmentOther
Mental State, cognitive function, and life quality will be examined using the Generalized Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire-9(PHQ-9), Rivermead post-concussion symptoms questionnaire(RPQ), PTSD Checklist-5 Version(PCL-5)，Six-Item Screener（SIS） and 12-Item Short-Form Health Survey version 2(SF-12v2).
Peripheral blood testOther
Collect peripheral blood samples from patients.
Hematoma testOther
Collect hematoma fluid, dura mater, and hematoma outer membrane samples from patients.
| Study group | Role | What they receive |
|---|---|---|
| TBI Group | TBI patients recruited from neurosurgical departments at 50 medical centers in China have apparent clinical symptoms that are confirmed by computed tomography or magnetic resonance imaging.
The exclusion criteria are those who fulfill one of the following conditions:
1. patients ≥90 years of age;
2. patients who did not accept follow-up visits or were unable to complete follow-up assessments;
3. patients with incomplete information;
4. patients who did not obtain written informed consent;
5. patients with concomitant cancer or other serious illnesses. Receives: Other: Neurological function; Other: Mental State, cognitive function, and life quality assessment; Other: Peripheral blood test; Other: Hematoma test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the Extended Glasgow Outcome Score
The Extended Glasgow Outcome Scores(GOSE) range from 1 to 8, with higher scores indicating a better outcome. The summary of the scale is below:1.Dead;2. Vegetative State;3. Lower Severe Disability;4. Upper Severe Disability;5. Lower Moderate Disability;6. Upper Moderate Disability;7. Lower Good Recovery;8.Upper Good Recovery.Therefore, a score of 1 represents the worst outcome (death), and a score of 8 represents the best outcome (upper good recovery).
The rates of death or severe disability (GOSE scores 1-3) due to traumatic brain injury in the short term (at discharge) and in the long term (3, 6, and 12 months post-discharge) give an indication of the extent to which a patient recovers from different treatments.
Measured: From discharge up to 12 months postoperatively
Secondary outcomes (7)
Difference in the Generalized Anxiety Disorder-7 Scale in post-traumatic mental health recovery
Patients were scored on their subsequent level of mental health at 3, 6, and 12 months after discharge based on the Generalized Anxiety Disorder-7 Scale(GAD-7).
The GAD-7 scale consists of seven items, each describing a symptom of Generalized Anxiety Disorder(GAD), and respondents rate how often they've been bothered by each symptom over the past two weeks.The GAD-7 score of 10 suggests moderate anxiety, on a scale ranging from 0 (minimal anxiety) to 21 (severe anxiety), with higher scores indicating worse outcomes.
Measured: From discharge up to 12 months postoperatively
Difference in the Patient Health Questionnaire-9 Scale in post-traumatic mental health recovery
Patients were scored on their subsequent level of mental health at 3, 6, and 12 months after discharge based on the Patient Health Questionnaire-9 Scale(PHQ-9).
The PHQ-9 scale consists of nine items, each describing a symptom of depression, and respondents rate how often they've been bothered by each symptom over the past two weeks. The PHQ-9 scores between 10-14 suggest moderate depression, on a scale ranging from 0 (minimal depression) to 27 (severe depression), with higher scores indicating worse outcomes.
Measured: From discharge up to 12 months postoperatively
Difference in the Rivermead Post-Concussive Symptoms Questionnaire Scale in post-traumatic mental health recovery
Patients were scored on their subsequent level of mental health at 3, 6, and 12 months after discharge based on the Rivermead Post-Concussive Symptoms Questionnaire(RPQ).
The RPQ score ranges from 0 (no symptoms) to 64 (severe symptoms). Higher scores on the RPQ indicate a greater severity of post-concussive symptoms and a worse outcome. This information helps healthcare providers assess the impact of the concussion on the patient's daily life and track their recovery progress.
Measured: From discharge up to 12 months postoperatively
Difference in the Post-Traumatic Stress Disorder Checklist-5 Scale in post-traumatic mental health recovery
Patients were scored on their subsequent level of mental health at 3, 6, and 12 months after discharge based on the Post-Traumatic Stress Disorder Checklist-5 (PCL-5). Each of the 20 items on the PCL-5 is rated on a scale from 0 ("Not at all") to 4 ("Extremely"). The PCL-5 score ranges from 0 to 80, with higher scores indicating worse Post-traumatic stress disorder(PTSD) symptoms.
Measured: From discharge up to 12 months postoperatively
Difference in life quality assessment
Patients were scored on their subsequent level of quality of life at 3, 6, and 12 months after discharge based on different scores on the 12-item Short-Form Health Survey 2 (SF-12v2).
The SF-12v2 provides two summary scores: the Physical Component Summary (PCS) score and the Mental Component Summary (MCS) score. For both the PCS and MCS scores range from 0(the lowest level of health) to 100(the highest level of health). Higher scores on the PCS and MCS indicate better physical and mental health, respectively.
Measured: From discharge up to 12 months postoperatively
Difference in cognitive function
Patients were scored on their subsequent level of cognitive function at 3, 6, and 12 months after discharge based on different scores on the Six-Item Screener (SIS).
The SIS is a brief cognitive assessment tool used primarily to screen for cognitive impairment. The SIS assesses orientation and recall, two critical components often affected in cognitive disorders such as dementia.It ranges from 0 to 6, with higher scores mean a better outcome in terms of cognitive function.
Measured: From discharge up to 12 months postoperatively
Rate of complications and adverse events
Rates of complications and adverse events during hospitalization and 12 months after discharge.
Measured: From discharge up to 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start1 Aug 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe 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
- 2,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weiming Liu, Beijing Tiantan Hospital
- Investigators
- Weiming Liu, M.D., Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06429774
- Sponsor's protocol ID
- SF 2024-1-2042
- Status last verified
- Aug 2024
- First submitted
- 16 May 2024
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Capizzi A, Woo J, Verduzco-Gutierrez M. Traumatic Brain Injury: An Overview of Epidemiology, Pathophysiology, and Medical Management. Med Clin North Am. 2020 Mar;104(2):213-238. doi: 10.1016/j.mcna.2019.11.001.
PubMed 32035565Galgano M, Toshkezi G, Qiu X, Russell T, Chin L, Zhao LR. Traumatic Brain Injury: Current Treatment Strategies and Future Endeavors. Cell Transplant. 2017 Jul;26(7):1118-1130. doi: 10.1177/0963689717714102.
PubMed 28933211Jiang JY, Gao GY, Feng JF, Mao Q, Chen LG, Yang XF, Liu JF, Wang YH, Qiu BH, Huang XJ. Traumatic brain injury in China. Lancet Neurol. 2019 Mar;18(3):286-295. doi: 10.1016/S1474-4422(18)30469-1. Epub 2019 Feb 12.
PubMed 30784557Stocchetti N, Carbonara M, Citerio G, Ercole A, Skrifvars MB, Smielewski P, Zoerle T, Menon DK. Severe traumatic brain injury: targeted management in the intensive care unit. Lancet Neurol. 2017 Jun;16(6):452-464. doi: 10.1016/S1474-4422(17)30118-7.
PubMed 28504109Steyerberg EW, Wiegers E, Sewalt C, Buki A, Citerio G, De Keyser V, Ercole A, Kunzmann K, Lanyon L, Lecky F, Lingsma H, Manley G, Nelson D, Peul W, Stocchetti N, von Steinbuchel N, Vande Vyvere T, Verheyden J, Wilson L, Maas AIR, Menon DK; CENTER-TBI Participants and Investigators. Case-mix, care pathways, and outcomes in patients with traumatic brain injury in CENTER-TBI: a European prospective, multicentre, longitudinal, cohort study. Lancet Neurol. 2019 Oct;18(10):923-934. doi: 10.1016/S1474-4422(19)30232-7.
PubMed 31526754Silverberg ND, Duhaime AC, Iaccarino MA. Mild Traumatic Brain Injury in 2019-2020. JAMA. 2020 Jan 14;323(2):177-178. doi: 10.1001/jama.2019.18134. No abstract available.
PubMed 31816030Sun D, Jiang B, Ru X, Sun H, Fu J, Wu S, Wang L, Wang L, Zhang M, Liu B, Wang W; for the NESS-China investigators. Prevalence and Altered Causes of Traumatic Brain Injury in China: A Nationwide Survey in 2013. Neuroepidemiology. 2020;54(2):106-113. doi: 10.1159/000501911. Epub 2019 Dec 18.
PubMed 31851999
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Intervention in Multi-level Hospitals for Acute Traumatic Brain Injury: a Prospective, Multicenter, Observational Cohort Study
- ClinicalTrials.gov ID
- NCT06429774
- Acronym / sponsor ID
- SF 2024-1-2042
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic Brain Injury, Beijing-Tianjin-Hebei region, Database, Comparative effectiveness of intervention, Clinical Treatment Guideline
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 May 2024 (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.
A prospective, multicenter, observational cohort study is designed to compare the effectiveness of intervention in multi-grade hospitals for acute traumatic brain injury and to optimize clinical outcomes.
Detailed description
Traumatic brain injury (TBI) is associated with significant morbidity, mortality, and disability, profoundly impacting public health. This study aims to establish a database for acute craniocerebral trauma within the Beijing-Tianjin-Hebei region, and compiles indicators of hospital treatment capabilities and patient data, including neuroimaging, clinical progression, and rehabilitation prognoses.The study is bifurcated into two segments: the initial phase surveys the current status of acute treatment outcomes for TBI inpatients across hospitals in the Beijing-Tianjin-Hebei region and conducts a comparative effectiveness analysis to identify the clinical interventions to optimize. Subsequent phases build on the former by applying optimized treatment strategies to improve efficacy and establish collaborative optimized treatment protocols.
This is a prospective, multicenter, observational study designed to enroll 2,000 patients under the age of 90 years with traumatic brain injury in the presence of clinical symptoms confirmed by computed tomography or magnetic resonance imaging.The primary outcome is the Extended Glasgow Outcome Score within 12 months. Secondary outcomes include the Generalized Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire-9(PHQ-9), Rivermead post-concussion symptoms questionnaire(RPQ), PTSD Checklist-5 Version(PCL-5)，Six-Item Screener (SIS) and 12-Item Short-Form Health Survey version 2(SF-12v2).
The objective of this study is anticipated to the Beijing-Tianjin-Hebei region a 20 percent increase in the number of cases treated by optimized clinical practice guidelines and a 10 percent decrement in mortality and disability rates among TBI patients in the region.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TBI Group | – | Other: Neurological function, Other: Mental State, cognitive function, and life quality assessment, Other: Peripheral blood test, Other: Hematoma testTBI patients recruited from neurosurgical departments at 50 medical centers in China have apparent clinical symptoms that are confirmed by computed tomography or magnetic resonance imaging. The exclusion criteria are those who fulfill one of the following conditions: 1. patients ≥90 years of age; 2. patients who did not accept follow-up visits or were unable to complete follow-up assessments; 3. patients with incomplete information; 4. patients who did not obtain written informed consent; 5. patients with concomitant cancer or other serious illnesses. |
Who may qualify
- Ages
- 1 year to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- TBI patients recruited from neurosurgical departments at 50 medical centers in China have apparent clinical symptoms that are confirmed by computed tomography or magnetic resonance imaging.
Key inclusion criteria (3 listed)
- Patient (1 years to 89 years) presenting with clinical symptoms of traumatic brain injury
- Traumatic brain injury verified on cranial computed tomography or magnetic resonance imaging
- Written informed consent from patients or their next of kin according to the patient's cognitive status
Key exclusion criteria (5 listed)
- patients ≥90 years of age
- patients who did not accept follow-up visits or were unable to complete follow-up assessments
- patients with incomplete information
- patients who did not obtain written informed consent
- patients with concomitant cancer or other serious illnesses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurological functionNeurological function will be examined using Glasgow Coma Scale (GCS) and Extended Glasgow Outcome Scale (GOSE).The GOSE was created as an advancement from the original GOS. The GOSE score categorizes the prognosis of patients with traumatic brain injury into eight categories.The 8 categories are: Dead, Vegetative State, Lower Severe Disability, Upper Severe Disability, Lower Moderate Disability, Upper Moderate Disability, Lower Good Recovery, and Upper Good Recovery. | Other | TBI Group |
| Mental State, cognitive function, and life quality assessmentMental State, cognitive function, and life quality will be examined using the Generalized Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire-9(PHQ-9), Rivermead post-concussion symptoms questionnaire(RPQ), PTSD Checklist-5 Version(PCL-5)，Six-Item Screener（SIS） and 12-Item Short-Form Health Survey version 2(SF-12v2). | Other | TBI Group |
| Peripheral blood testCollect peripheral blood samples from patients. | Other | TBI Group |
| Hematoma testCollect hematoma fluid, dura mater, and hematoma outer membrane samples from patients. | Other | TBI Group |
Primary outcome
Difference in the Extended Glasgow Outcome Score
Time frame: From discharge up to 12 months postoperatively
The Extended Glasgow Outcome Scores(GOSE) range from 1 to 8, with higher scores indicating a better outcome. The summary of the scale is below:1.Dead;2. Vegetative State;3. Lower Severe Disability;4. Upper Severe Disability;5. Lower Moderate Disability;6. Upper Moderate Disability;7. Lower Good Recovery;8.Upper Good Recovery.Therefore, a score of 1 represents the worst outcome (death), and a score of 8 represents the best outcome (upper good recovery). The rates of death or severe disability (GOSE scores 1-3) due to traumatic brain injury in the short term (at discharge) and in the long term (3, 6, and 12 months post-discharge) give an indication of the extent to which a patient recovers from different treatments.
7 secondary outcomes
Difference in the Generalized Anxiety Disorder-7 Scale in post-traumatic mental health recovery
Time frame: From discharge up to 12 months postoperatively
Difference in the Patient Health Questionnaire-9 Scale in post-traumatic mental health recovery
Time frame: From discharge up to 12 months postoperatively
Difference in the Rivermead Post-Concussive Symptoms Questionnaire Scale in post-traumatic mental health recovery
Time frame: From discharge up to 12 months postoperatively
Difference in the Post-Traumatic Stress Disorder Checklist-5 Scale in post-traumatic mental health recovery
Time frame: From discharge up to 12 months postoperatively
Difference in life quality assessment
Time frame: From discharge up to 12 months postoperatively
Difference in cognitive function
Time frame: From discharge up to 12 months postoperatively
Rate of complications and adverse events
Time frame: From discharge up to 12 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Background: PubMed 32035565Capizzi A, Woo J, Verduzco-Gutierrez M. Traumatic Brain Injury: An Overview of Epidemiology, Pathophysiology, and Medical Management. Med Clin North Am. 2020 Mar;104(2):213-238. doi: 10.1016/j.mcna.2019.11.001.
- Background: PubMed 28933211Galgano M, Toshkezi G, Qiu X, Russell T, Chin L, Zhao LR. Traumatic Brain Injury: Current Treatment Strategies and Future Endeavors. Cell Transplant. 2017 Jul;26(7):1118-1130. doi: 10.1177/0963689717714102.
- Background: PubMed 30784557Jiang JY, Gao GY, Feng JF, Mao Q, Chen LG, Yang XF, Liu JF, Wang YH, Qiu BH, Huang XJ. Traumatic brain injury in China. Lancet Neurol. 2019 Mar;18(3):286-295. doi: 10.1016/S1474-4422(18)30469-1. Epub 2019 Feb 12.
- Background: PubMed 28504109Stocchetti N, Carbonara M, Citerio G, Ercole A, Skrifvars MB, Smielewski P, Zoerle T, Menon DK. Severe traumatic brain injury: targeted management in the intensive care unit. Lancet Neurol. 2017 Jun;16(6):452-464. doi: 10.1016/S1474-4422(17)30118-7.
- Background: PubMed 31526754Steyerberg EW, Wiegers E, Sewalt C, Buki A, Citerio G, De Keyser V, Ercole A, Kunzmann K, Lanyon L, Lecky F, Lingsma H, Manley G, Nelson D, Peul W, Stocchetti N, von Steinbuchel N, Vande Vyvere T, Verheyden J, Wilson L, Maas AIR, Menon DK; CENTER-TBI Participants and Investigators. Case-mix, care pathways, and outcomes in patients with traumatic brain injury in CENTER-TBI: a European prospective, multicentre, longitudinal, cohort study. Lancet Neurol. 2019 Oct;18(10):923-934. doi: 10.1016/S1474-4422(19)30232-7.
- Background: PubMed 31816030Silverberg ND, Duhaime AC, Iaccarino MA. Mild Traumatic Brain Injury in 2019-2020. JAMA. 2020 Jan 14;323(2):177-178. doi: 10.1001/jama.2019.18134. No abstract available.
- Background: PubMed 31851999Sun D, Jiang B, Ru X, Sun H, Fu J, Wu S, Wang L, Wang L, Zhang M, Liu B, Wang W; for the NESS-China investigators. Prevalence and Altered Causes of Traumatic Brain Injury in China: A Nationwide Survey in 2013. Neuroepidemiology. 2020;54(2):106-113. doi: 10.1159/000501911. Epub 2019 Dec 18.
- Individual participant dataSharing planned: No
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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.
Weiming Liu, M.D. principal investigator
Beijing Tiantan Hospital
64 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by Beijing Tiantan Hospital at 64 sites 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 64 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weiming Liu, M.D. (13701182770, liuweimingnsok@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the Extended Glasgow Outcome Score (time frame: From discharge up to 12 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06429774, which also lists 7 linked publications.
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 4 Sep 2024.