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

Last updated: August 30, 2024
Sponsor: Beijing Tiantan Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Traumatic Brain Injury

Memory Loss

Neurologic Disorders

Treatment

Mental State, cognitive function, and life quality assessment

Neurological function

Hematoma test

Clinical Study ID

NCT06429774
SF 2024-1-2042
  • Ages 1-89
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient (1 years to 89 years) presenting with clinical symptoms of traumatic braininjury

  • Traumatic brain injury verified on cranial computed tomography or magnetic resonanceimaging

  • Written informed consent from patients or their next of kin according to thepatient's cognitive status

Exclusion

Exclusion Criteria:

  • patients ≥90 years of age

  • patients who did not accept follow-up visits or were unable to complete follow-upassessments

  • patients with incomplete information

  • patients who did not obtain written informed consent

  • patients with concomitant cancer or other serious illnesses

Study Design

Total Participants: 2000
Treatment Group(s): 4
Primary Treatment: Mental State, cognitive function, and life quality assessment
Phase:
Study Start date:
August 01, 2024
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Beijing Changping Hospital

    Beijing, Beijing 102200
    China

    Site Not Available

  • Beijing Chaoyang Hospital, Capital Medical University

    Beijing, Beijing 100020
    China

    Site Not Available

  • Beijing Chaoyang Integrative Medicine Rescue And First Aid Hospital

    Beijing, Beijing 100020
    China

    Site Not Available

  • Beijing Daxing District People's Hospital

    Beijing, Beijing 100020
    China

    Site Not Available

  • Beijing Fengtai You'anmen Hospital

    Beijing, Beijing 100000
    China

    Site Not Available

  • Beijing HuaSheng Rehabilitation Hospital

    Beijing, Beijing 100000
    China

    Site Not Available

  • Beijing Huairou Hospital

    Beijing, Beijing 100000
    China

    Site Not Available

  • Beijing Luhe Hospital,Capital Medical University

    Beijing, Beijing 100000
    China

    Site Not Available

  • Beijing Mentougou District Hospital

    Beijing, Beijing 102300
    China

    Site Not Available

  • Beijing Pinggu Hospital

    Beijing, Beijing 101200
    China

    Site Not Available

  • Beijing Red Cross Emergency Medical Center

    Beijing, Beijing 100000
    China

    Site Not Available

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing 100070
    China

    Active - Recruiting

  • Beijing Tsinghua Changgung Hospital

    Beijing, Beijing 100000
    China

    Active - Recruiting

  • Dongfang Hospital of Beijing University of Chinese Medicine

    Beijing, Beijing 102401
    China

    Site Not Available

  • Liangxiang Hospital

    Beijing, Beijing 102400
    China

    Site Not Available

  • Peking University International Hospital

    Beijing, Beijing 100020
    China

    Site Not Available

  • Peking University People's Hospital

    Beijing, Beijing 100000
    China

    Site Not Available

  • The First Hospital of Fangshan District, Bejing

    Beijing, Beijing 102400
    China

    Site Not Available

  • Affiliated Hospital Of Hebei University

    Baoding, Hebei 071000
    China

    Site Not Available

  • Anguo Hospital

    Baoding, Hebei 071200
    China

    Site Not Available

  • Bao Ding No.1 Central Hospital

    Baoding, Hebei 071000
    China

    Site Not Available

  • Baoding Seventh Hospital

    Baoding, Hebei 072150
    China

    Site Not Available

  • Gaobeidian Hospital

    Baoding, Hebei 074099
    China

    Active - Recruiting

  • Rongcheng People's Hospital

    Baoding, Hebei 071799
    China

    Site Not Available

  • The Fourth Central Hospital of Baoding City

    Baoding, Hebei 072350
    China

    Site Not Available

  • The No.2 Hospital of Baoding

    Baoding, Hebei 071000
    China

    Site Not Available

  • Xiongxian Hospital

    Baoding, Hebei 071800
    China

    Site Not Available

  • Yixian Hospital

    Baoding, Hebei 074299
    China

    Site Not Available

  • Suning Hospital

    Cangzhou, Hebei 062350
    China

    Site Not Available

  • Affiliated Hospital Of Chengde Medical University

    Chengde, Hebei 067000
    China

    Site Not Available

  • Luanping Hospital

    Chengde, Hebei 068250
    China

    Site Not Available

  • Pingquan Hospital

    Chengde, Hebei 067599
    China

    Site Not Available

  • Handan Central Hospital

    Handan, Hebei 056000
    China

    Site Not Available

  • Hangang Hospital

    Handan, Hebei 056000
    China

    Site Not Available

  • The No.1 Hospital Of Yongnian District Handan City

    Handan, Hebei 057150
    China

    Site Not Available

  • Weixian Chinese Traditional Medicine Hospital

    Handan, Hebei 056800
    China

    Site Not Available

  • Raoyang People's Hospital

    Hengyang, Hebei 053900
    China

    Site Not Available

  • Dachang Hui Autonomous County People's Hospital

    Langfang, Hebei 065300
    China

    Site Not Available

  • Dacheng Hospital

    Langfang, Hebei 065900
    China

    Site Not Available

  • Edelburg Hospital

    Langfang, Hebei 065099
    China

    Site Not Available

  • Fourth people's Hospital of Langfang

    Langfang, Hebei 065701
    China

    Site Not Available

  • Hebei Petro China Central Hospital

    Langfang, Hebei 065000
    China

    Site Not Available

  • Langfang People's Hospital

    Langfang, Hebei 065000
    China

    Site Not Available

  • Langfang People's Hospital

    Langfang, Hebei 065000
    China

    Site Not Available

  • Sanhe Hospital

    Langfang, Hebei 065201
    China

    Site Not Available

  • Xianghe Hospital

    Langfang, Hebei 065400
    China

    Site Not Available

  • Yanjiao Fuhe No.1 Hospital

    Langfang, Hebei 065201
    China

    Site Not Available

  • First Hospital of Qinhuangdao

    Qinhuangdao, Hebei 066199
    China

    Site Not Available

  • Lulong Hospital

    Qinhuangdao, Hebei 066499
    China

    Site Not Available

  • Peking University Third Hospital Qinhuangdao Hospital

    Qinhuangdao, Hebei 100083
    China

    Site Not Available

  • Qinhuangdao Funing District Hospital of Traditional Chinese Medicine

    Qinhuangdao, Hebei 066399
    China

    Site Not Available

  • Shanhaiguan People's Hospital

    Qinhuangdao, Hebei 066299
    China

    Site Not Available

  • The Second Hospital of Hebei Medical University

    Shijia Zhuang, Hebei 050061
    China

    Site Not Available

  • Gaoyi Hospital

    Shijiazhuang, Hebei 051330
    China

    Site Not Available

  • Hebei Chest Hospital

    Shijiazhuang, Hebei 050041
    China

    Site Not Available

  • Hebei Medical University Third Hospital

    Shijiazhuang, Hebei 050000
    China

    Site Not Available

  • Jingxing Hospital

    Shijiazhuang, Hebei 050300
    China

    Site Not Available

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei 050000
    China

    Site Not Available

  • The Third Hospital Of Shijiazhuang

    Shijiazhuang, Hebei 050000
    China

    Site Not Available

  • Xibaipo Rescue Center

    Shijiazhuang, Hebei 050411
    China

    Site Not Available

  • Xinle Chinese Traditional Medicine Hospital

    Shijiazhuang, Hebei 050700
    China

    Site Not Available

  • Yuanshi Chinese Traditional Medicine Hospital

    Shijiazhuang, Hebei 051130
    China

    Site Not Available

  • People's Hospital Of Zunhua

    Tangshan, Hebei 064200
    China

    Site Not Available

  • Tangshan Fengrun People's Hospital

    Tangshan, Hebei 063000
    China

    Site Not Available

  • Tangshan Workers' Hospital

    Tangshan, Hebei 063000
    China

    Site Not Available

  • LinCheng People's Hospital

    Xingtai, Hebei 054300
    China

    Site Not Available

  • Pingxiang People's Hospital

    Xingtai, Hebei 054599
    China

    Site Not Available

  • Qinghe Central Hospital

    Xingtai, Hebei 054802
    China

    Site Not Available

  • Wei County People's Hospital

    Xingtai, Hebei 054799
    China

    Site Not Available

  • Xingtai Central Hospital

    Xingtai, Hebei 054000
    China

    Site Not Available

  • Xingtai Nanhe District People's Hospital

    Xingtai, Hebei 054499
    China

    Site Not Available

  • Xingtai Ninth Hospital

    Xingtai, Hebei 055250
    China

    Site Not Available

  • Xingtai People's Hospital

    Xingtai, Hebei 054001
    China

    Site Not Available

  • Xingtai Xindu District People's Hospital

    Xingtai, Hebei 054001
    China

    Site Not Available

  • Tianjin First Central Hospital

    Tianjin, Tianjin 300000
    China

    Site Not Available

  • Tianjin Fourth Central Hospital

    Tianjin, Tianjin 300074
    China

    Site Not Available

  • Tianjin Hospital

    Tianjin, Tianjin 300000
    China

    Site Not Available

  • Tianjin Xiqing Hospital

    Tianjin, Tianjin 300381
    China

    Site Not Available

  • Wuqing People's Hospital

    Tianjin, Tianjin 301799
    China

    Site Not Available

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