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

Traumatic Brain Injury Clinical Trial

Official title:

Comparative Effectiveness of Intervention in Multi-level Hospitals for Acute Traumatic Brain Injury: a Prospective, Multicenter, Observational Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06429774
• Other study ID #: SF 2024-1-2042
• Status: Not yet recruiting
• Start date: July 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2024
• Source: Beijing Tiantan Hospital
• Contact: Weiming Liu, M.D.
• Phone: 13701182770
• Email: liuweimingnsok[@]sina.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

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.
• 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).
• Peripheral blood test
Collect peripheral blood samples from patients.
• Hematoma test
Collect hematoma fluid, dura mater, and hematoma outer membrane samples from patients.

Locations

Country	Name	City	State
China	Affiliated Hospital Of Hebei University	Baoding	Hebei
China	Anguo Hospital	Baoding	Hebei
China	Bao Ding No.1 Central Hospital	Baoding	Hebei
China	Gaobeidian Hospital	Baoding	Hebei
China	The Fourth Central Hospital of Baoding City	Baoding	Hebei
China	The No.2 Hospital of Baoding	Baoding	Hebei
China	Xiongxian Hospital	Baoding	Hebei
China	Beijing Changping Hospital	Beijing	Beijing
China	Beijing Chaoyang Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Chaoyang Integrative Medicine Rescue And First Aid Hospital	Beijing	Beijing
China	Beijing Daxing District People's Hospital	Beijing	Beijing
China	Beijing Fengtai You'anmen Hospital	Beijing	Beijing
China	Beijing Huairou Hospital	Beijing	Beijing
China	Beijing HuaSheng Rehabilitation Hospital	Beijing	Beijing
China	Beijing Luhe Hospital,Capital Medical University	Beijing	Beijing
China	Beijing Mentougou District Hospital	Beijing	Beijing
China	Beijing Pinggu Hospital	Beijing	Beijing
China	Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Tsinghua Changgung Hospital	Beijing	Beijing
China	Liangxiang Hospital	Beijing	Beijing
China	Peking University International Hospital	Beijing	Beijing
China	Peking University People's Hospital	Beijing	Beijing
China	The First Hospital of Fangshan District, Bejing	Beijing	Beijing
China	Suning Hospital	Cangzhou	Hebei
China	Affiliated Hospital Of Chengde Medical University	Chengde	Hebei
China	Luanping Hospital	Chengde	Hebei
China	Handan Central Hospital	Handan	Hebei
China	Hangang Hospital	Handan	Hebei
China	The No.1 Hospital Of Yongnian District Handan City	Handan	Hebei
China	Weixian Chinese Traditional Medicine Hospital	Handan	Hebei
China	Raoyang People's Hospital	Hengyang	Hebei
China	Dachang Hui Autonomous County People's Hospital	Langfang	Hebei
China	Langfang People's Hospital	Langfang	Hebei
China	Xianghe Hospital	Langfang	Hebei
China	Yanjiao Fuhe No.1 Hospital	Langfang	Hebei
China	Gaoyi Hospital	Shijiazhuang	Hebei
China	Hebei Chest Hospital	Shijiazhuang	Hebei
China	Hebei Medical University Third Hospital	Shijiazhuang	Hebei
China	Jingxing Hospital	Shijiazhuang	Hebei
China	The Fourth Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	The Third Hospital Of Shijiazhuang	Shijiazhuang	Hebei
China	Xibaipo Rescue Center	Shijiazhuang	Hebei
China	Xinle Chinese Traditional Medicine Hospital	Shijiazhuang	Hebei
China	Yuanshi Chinese Traditional Medicine Hospital	Shijiazhuang	Hebei
China	People's Hospital Of Zunhua	Tangshan	Hebei
China	Tangshan Fengrun People's Hospital	Tangshan	Hebei
China	Tangshan Workers' Hospital	Tangshan	Hebei
China	Tianjin Hospital	Tianjin	Tianjin
China	LinCheng People's Hospital	Xingtai	Hebei
China	Qinghe Central Hospital	Xingtai	Hebei
China	Xingtai Central Hospital	Xingtai	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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