Clinical trial NCT06429774: Comparative Effectiveness of Intervention in Multi-level Hospitals for Acute Traumatic Brain Injury(Metric-TBI)
Official title: Comparative Effectiveness of Intervention in Multi-level Hospitals for Acute Traumatic Brain Injury: a Prospective, Multicenter, Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Traumatic Brain Injury
Keywords: Traumatic Brain Injury
Beijing-Tianjin-Hebei region
Database
Comparative effectiveness of intervention
Clinical Treatment Guideline
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 2000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 89
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Difference in the Extended Glasgow Outcome Score
timeFrame: From discharge up to 12 months postoperatively
Secondary outcomes:
measure: Difference in the Generalized Anxiety Disorder-7 Scale in post-traumatic mental health recovery
timeFrame: From discharge up to 12 months postoperatively
measure: Difference in the Patient Health Questionnaire-9 Scale in post-traumatic mental health recovery
timeFrame: From discharge up to 12 months postoperatively
measure: Difference in the Rivermead Post-Concussive Symptoms Questionnaire Scale in post-traumatic mental health recovery
timeFrame: From discharge up to 12 months postoperatively
measure: Difference in the Post-Traumatic Stress Disorder Checklist-5 Scale in post-traumatic mental health recovery
timeFrame: From discharge up to 12 months postoperatively
measure: Difference in life quality assessment
timeFrame: From discharge up to 12 months postoperatively
measure: Difference in cognitive function
timeFrame: From discharge up to 12 months postoperatively
measure: Rate of complications and adverse events
timeFrame: From discharge up to 12 months postoperatively
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Fengtai You'anmen Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Huairou Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Luhe Hospital,Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Red Cross Emergency Medical Center
state: Beijing
city: Beijing
country: China
facility: Beijing Tsinghua Changgung Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Chaoyang Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Chaoyang Integrative Medicine Rescue And First Aid Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Daxing District People's Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University International Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Changping Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Mentougou District Hospital
state: Beijing
city: Beijing
country: China
facility: Liangxiang Hospital
state: Beijing
city: Beijing
country: China
facility: The First Hospital of Fangshan District, Bejing
state: Beijing
city: Beijing
country: China
facility: Dongfang Hospital of Beijing University of Chinese Medicine
state: Beijing
city: Baoding
country: China
facility: Affiliated Hospital Of Hebei University
state: Hebei
city: Baoding
country: China
facility: The No.2 Hospital of Baoding
state: Hebei
city: Baoding
country: China
facility: Anguo Hospital
state: Hebei
city: Baoding
country: China
facility: Rongcheng People's Hospital
state: Hebei
city: Baoding
country: China
facility: Xiongxian Hospital
state: Hebei
city: Baoding
country: China
facility: Baoding Seventh Hospital
state: Hebei
city: Baoding
country: China
facility: Gaobeidian Hospital
state: Hebei
city: Baoding
country: China
facility: Yixian Hospital
state: Hebei
city: Cangzhou
country: China
facility: Suning Hospital
state: Hebei
city: Chengde
country: China
facility: Pingquan Hospital
state: Hebei
city: Chengde
country: China
facility: Luanping Hospital
state: Hebei
city: Handan
country: China
facility: Hangang Hospital
state: Hebei
city: Handan
country: China
facility: Weixian Chinese Traditional Medicine Hospital
state: Hebei
city: Handan
country: China
facility: The No.1 Hospital Of Yongnian District Handan City
state: Hebei
city: Langfang
country: China
facility: Hebei Petro China Central Hospital
state: Hebei
city: Langfang
country: China
facility: Langfang People&#39;s Hospital
state: Hebei
city: Langfang
country: China
facility: Edelburg Hospital
state: Hebei
city: Langfang
country: China
facility: Sanhe Hospital
state: Hebei
city: Langfang
country: China
facility: Yanjiao Fuhe No.1 Hospital
state: Hebei
city: Langfang
country: China
facility: Dachang Hui Autonomous County People's Hospital
state: Hebei
city: Langfang
country: China
facility: Xianghe Hospital
state: Hebei
city: Langfang
country: China
facility: Fourth people's Hospital of Langfang
state: Hebei
city: Langfang
country: China
facility: Dacheng Hospital
state: Hebei
city: Qinhuangdao
country: China
facility: First Hospital of Qinhuangdao
state: Hebei
city: Qinhuangdao
country: China
facility: Shanhaiguan People's Hospital
state: Hebei
city: Qinhuangdao
country: China
facility: Qinhuangdao Funing District Hospital of Traditional Chinese Medicine
state: Hebei
city: Qinhuangdao
country: China
facility: Lulong Hospital
state: Hebei
city: Qinhuangdao
country: China
facility: Peking University Third Hospital Qinhuangdao Hospital
state: Hebei
city: Shijia Zhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Shijiazhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
state: Hebei
city: Shijiazhuang
country: China
facility: The Third Hospital Of Shijiazhuang
state: Hebei
city: Shijiazhuang
country: China
facility: Jingxing Hospital
state: Hebei
city: Shijiazhuang
country: China
facility: Xinle Chinese Traditional Medicine Hospital
state: Hebei
city: Tangshan
country: China
facility: Tangshan Fengrun People's Hospital
state: Hebei
city: Tangshan
country: China
facility: Tangshan Workers' Hospital
state: Hebei
city: Xingtai
country: China
facility: Xingtai Central Hospital
state: Hebei
city: Xingtai
country: China
facility: Xingtai People's Hospital
state: Hebei
city: Xingtai
country: China
facility: Xingtai Xindu District People's Hospital
state: Hebei
city: Xingtai
country: China
facility: Xingtai Nanhe District People's Hospital
state: Hebei
city: Xingtai
country: China
facility: Pingxiang People's Hospital
state: Hebei
city: Xingtai
country: China
facility: Wei County People's Hospital
state: Hebei
city: Xingtai
country: China
facility: Qinghe Central Hospital
state: Hebei
city: Xingtai
country: China
facility: Xingtai Ninth Hospital
state: Hebei
city: Tianjin
country: China
facility: Tianjin First Central Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Fourth Central Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Xiqing Hospital
state: Tianjin
city: Tianjin
country: China
facility: Wuqing People's Hospital
state: Tianjin
Study officials:
affiliation: Beijing Tiantan Hospital
name: Weiming Liu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Galgano 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.
citation: Jiang 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.
citation: Stocchetti 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.
citation: Steyerberg 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.
citation: Silverberg 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.
citation: Sun 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.