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

Overview

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.

Interventions

• 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).
• 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.

Primary outcome measures

• Difference in the Extended Glasgow Outcome Score [Time frame: From discharge up to 12 months postoperatively]

Secondary outcome measures (7)

• 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

China · 64 centers

• Beijing Fengtai You'anmen Hospital — Beijing
• Beijing Huairou Hospital — Beijing
• Beijing Luhe Hospital,Capital Medical University — Beijing
• Beijing Red Cross Emergency Medical Center — Beijing
• Beijing Tsinghua Changgung Hospital — Beijing
• Peking University People's Hospital — Beijing
• Beijing Chaoyang Hospital, Capital Medical University — Beijing
• Beijing Chaoyang Integrative Medicine Rescue And First Aid Hospital — Beijing
• … and 56 more centers

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. PMID 32035565
• 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. PMID 28933211
• 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. PMID 30784557
• 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. PMID 28504109
• 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, PMID 31526754
• 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. PMID 31816030
• 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. PMID 31851999

Identifiers

NCT: NCT06429774 · SF 2024-1-2042

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗