Comparative Effectiveness of Intervention in Multi-level Hospitals for Acute Traumatic Brain Injury(Metric-TBI)

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.

Study Overview

• Status: Recruiting
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Other: Peripheral blood test; Other: Hematoma test; Other: Neurological function; Other: Mental State, cognitive function, and life quality assessment

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 Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Weiming Liu, M.D.; Phone Number: 13701182770; Email: liuweimingnsok@sina.com
• Study Contact Backup: Name: Yu Shi, M.D.; Phone Number: 13611533819; Email: shiyu199709@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100070
      • Recruiting
      • Beijing Tiantan Hospital, Capital Medical University
      • Contact: Weiming Liu, MD; Phone Number: +86 13701182770; Email: liuweimingnsok@sina.com
      • Principal Investigator: Weiming Liu, MD
      • Sub-Investigator: Guoyi Gao, MD
      • Sub-Investigator: Dongling Sun, MD
    • Beijing, Beijing, China, 100020
      • Not yet recruiting
      • Beijing Chaoyang Hospital, Capital Medical University
    • Beijing, Beijing, China, 100000
      • Not yet recruiting
      • Peking University People's Hospital
    • Beijing, Beijing, China, 100000
      • Not yet recruiting
      • Beijing Fengtai You'anmen Hospital
    • Beijing, Beijing, China, 100000
      • Not yet recruiting
      • Beijing Huairou Hospital
    • Beijing, Beijing, China, 100000
      • Not yet recruiting
      • Beijing Luhe Hospital,Capital Medical University
    • Beijing, Beijing, China, 100000
      • Not yet recruiting
      • Beijing Red Cross Emergency Medical Center
    • Beijing, Beijing, China, 100020
      • Not yet recruiting
      • Beijing Chaoyang Integrative Medicine Rescue And First Aid Hospital
    • Beijing, Beijing, China, 100020
      • Not yet recruiting
      • Beijing Daxing District People'S Hospital
    • Beijing, Beijing, China, 100020
      • Not yet recruiting
      • Peking University International Hospital
    • Beijing, Beijing, China, 102200
      • Not yet recruiting
      • Beijing Changping Hospital
    • Beijing, Beijing, China, 102300
      • Not yet recruiting
      • Beijing Mentougou District Hospital
    • Beijing, Beijing, China, 102400
      • Not yet recruiting
      • Liangxiang Hospital
    • Beijing, Beijing, China, 102400
      • Not yet recruiting
      • The First Hospital of Fangshan District, Bejing
    • Beijing, Beijing, China, 102401
      • Not yet recruiting
      • Dongfang Hospital of Beijing University of Chinese Medicine
      • Contact: Gesheng Wang, M.D.; Phone Number: +86 13581759316
    • Beijing, Beijing, China, 100000
      • Recruiting
      • Beijing Tsinghua Changgung Hospital
  • Hebei
    • Baoding, Hebei, China, 071000
      • Not yet recruiting
      • Affiliated Hospital of Hebei University
    • Baoding, Hebei, China, 071000
      • Not yet recruiting
      • The No.2 Hospital Of Baoding
    • Baoding, Hebei, China, 071200
      • Not yet recruiting
      • Anguo Hospital
    • Baoding, Hebei, China, 071799
      • Not yet recruiting
      • Rongcheng People's Hospital
    • Baoding, Hebei, China, 071800
      • Not yet recruiting
      • Xiongxian Hospital
    • Baoding, Hebei, China, 072150
      • Not yet recruiting
      • Baoding Seventh Hospital
    • Baoding, Hebei, China, 074099
      • Recruiting
      • Gaobeidian Hospital
    • Baoding, Hebei, China, 074299
      • Not yet recruiting
      • Yixian Hospital
    • Cangzhou, Hebei, China, 062350
      • Not yet recruiting
      • Suning Hospital
    • Chengde, Hebei, China, 067599
      • Not yet recruiting
      • Pingquan Hospital
    • Chengde, Hebei, China, 068250
      • Not yet recruiting
      • Luanping Hospital
    • Handan, Hebei, China, 056000
      • Not yet recruiting
      • Hangang Hospital
    • Handan, Hebei, China, 056800
      • Not yet recruiting
      • Weixian Chinese Traditional Medicine Hospital
    • Handan, Hebei, China, 057150
      • Not yet recruiting
      • The No.1 Hospital Of Yongnian District Handan City
    • Langfang, Hebei, China, 065000
      • Not yet recruiting
      • Hebei Petro China Central Hospital
    • Langfang, Hebei, China, 065099
      • Not yet recruiting
      • Edelburg Hospital
    • Langfang, Hebei, China, 065201
      • Not yet recruiting
      • Sanhe Hospital
    • Langfang, Hebei, China, 065201
      • Not yet recruiting
      • Yanjiao Fuhe No.1 Hospital
    • Langfang, Hebei, China, 065300
      • Not yet recruiting
      • Dachang Hui Autonomous County People's Hospital
    • Langfang, Hebei, China, 065400
      • Not yet recruiting
      • Xianghe Hospital
    • Langfang, Hebei, China, 065701
      • Not yet recruiting
      • Fourth people's Hospital of Langfang
    • Langfang, Hebei, China, 065900
      • Not yet recruiting
      • Dacheng Hospital
    • Langfang, Hebei, China, 065000
      • Recruiting
      • Langfang People's Hospital
    • Qinhuangdao, Hebei, China, 066199
      • Not yet recruiting
      • First Hospital of Qinhuangdao
    • Qinhuangdao, Hebei, China, 066299
      • Not yet recruiting
      • Shanhaiguan People's Hospital
    • Qinhuangdao, Hebei, China, 066399
      • Not yet recruiting
      • Qinhuangdao Funing District Hospital of Traditional Chinese Medicine
    • Qinhuangdao, Hebei, China, 066499
      • Not yet recruiting
      • Lulong Hospital
    • Qinhuangdao, Hebei, China, 100083
      • Not yet recruiting
      • Peking University Third Hospital Qinhuangdao Hospital
    • Shijia Zhuang, Hebei, China, 050061
      • Not yet recruiting
      • The Second Hospital of Hebei Medical University
    • Shijiazhuang, Hebei, China, 050000
      • Not yet recruiting
      • The Fourth Hospital of Hebei Medical University
    • Shijiazhuang, Hebei, China, 050000
      • Not yet recruiting
      • The Third Hospital of Shijiazhuang
    • Shijiazhuang, Hebei, China, 050300
      • Not yet recruiting
      • Jingxing Hospital
    • Shijiazhuang, Hebei, China, 050700
      • Not yet recruiting
      • Xinle Chinese Traditional Medicine Hospital
    • Tangshan, Hebei, China, 063000
      • Not yet recruiting
      • Tangshan Workers' Hospital
    • Tangshan, Hebei, China, 063000
      • Not yet recruiting
      • Tangshan Fengrun People's Hospital
    • Xingtai, Hebei, China, 054000
      • Not yet recruiting
      • Xingtai central hospital
    • Xingtai, Hebei, China, 054001
      • Not yet recruiting
      • Xingtai People's Hospital
    • Xingtai, Hebei, China, 054001
      • Not yet recruiting
      • Xingtai Xindu District People's Hospital
    • Xingtai, Hebei, China, 054499
      • Not yet recruiting
      • Xingtai Nanhe District People's Hospital
    • Xingtai, Hebei, China, 054599
      • Not yet recruiting
      • Pingxiang People's Hospital
    • Xingtai, Hebei, China, 054799
      • Not yet recruiting
      • Wei County People's Hospital
    • Xingtai, Hebei, China, 054802
      • Not yet recruiting
      • Qinghe Central Hospital
    • Xingtai, Hebei, China, 055250
      • Not yet recruiting
      • Xingtai Ninth Hospital
  • Tianjin
    • Tianjin, Tianjin, China, 300000
      • Not yet recruiting
      • Tianjin First Central Hospital
    • Tianjin, Tianjin, China, 300000
      • Not yet recruiting
      • Tianjin Hospital
    • Tianjin, Tianjin, China, 300074
      • Not yet recruiting
      • Tianjin Fourth Central Hospital
    • Tianjin, Tianjin, China, 300381
      • Not yet recruiting
      • Tianjin Xiqing Hospital
    • Tianjin, Tianjin, China, 301799
      • Not yet recruiting
      • WuQing People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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: 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.

Other: Peripheral blood test; Collect peripheral blood samples from patients.; Other: Hematoma test; Collect hematoma fluid, dura mater, and hematoma outer membrane samples from patients.; Other: Neurological function; 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.; Other: Mental State, cognitive function, and life quality assessment; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From discharge up to 12 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	From discharge up to 12 months postoperatively

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Investigators: Principal Investigator: Weiming Liu, M.D., Beijing Tiantan Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: May 16, 2024
• First Submitted That Met QC Criteria: May 23, 2024
• First Posted (Actual): May 28, 2024

Study Record Updates

• Last Update Posted (Actual): September 4, 2024
• Last Update Submitted That Met QC Criteria: August 30, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Traumatic Brain Injury; Database; Beijing-Tianjin-Hebei region; Comparative effectiveness of intervention; Clinical Treatment Guideline
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: SF 2024-1-2042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No