Collaborative European NeuroTrauma Effectiveness Research in TBI (CENTER-TBI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,559
- 试验地点
- 65
- 主要终点
- SF-12v2 Health Survey (Short-Form Health Survey With 12 Questions) at 6 Months
研究概览
简要总结
The research aims of the CENTER-TBI study are to:
- better characterize Traumatic Brain Injury (TBI) as a disease and describe it in a European context, and
- identify the most effective clinical interventions for managing TBI.
Specific aims
- To collect high quality clinical and epidemiological data with repositories for neuro-imaging, DNA, and serum from patients with TBI.
- To refine and improve outcome assessment and develop health utility indices for TBI.
- To develop multidimensional approaches to characterisation and prediction of TBI.
- To define patient profiles which predict efficacy of specific interventions ("Precision Medicine").
- To develop performance indicators for quality assurance and quality improvement in TBI care.
- To validate the common data elements (CDEs) for broader use in international settings, and to develop a user-friendly web based data entry instrument and case report form builder.
- To develop an open database compatible with Federal Interagency Traumatic Brain Injury Research (FITBIR).
- To intensify networking activities and international collaborations in TBI.
- To disseminate study results and management recommendations for TBI to health care professionals, policy makers and consumers, aiming to improve health care for TBI at individual and population levels.
- To develop a "knowledge commons" for TBI, integrating CENTER-TBI outputs into systematic reviews.
详细描述
• Introduction:
CENTER-TBI (Collaborative European NeuroTrauma Effectiveness Research in TBI) (www.center-tbi.eu) is a project embedded within the International Initiative on TBI Research (InTBIR) (http://intbir.nih.gov/), as a collaboration between the European Commission (EC), the US National Institute of Neurological Disorders and Stroke (NIH-NINDS) and the Canadian Institute of Health Research (CIHR).
- Research aims:
The basic concept of this project is to exploit the existing heterogeneity in biology, care and outcome of TBI patients to discover underlying pathophysiology, to refine characterisation, and to identify effective clinical interventions. The key driver of our research plan is to collect data from a large number of European centres and sufficiently large cohort to enable 'Comparative effectiveness research' (CER) analyses of differences in clinical care and management pathways in TBI.
Improved disease characterization will aid Precision Medicine, a concept recently enunciated by the US National Academy of Science. Such improved characterization and stratification will allow for more targeted therapies. Further, CER provides a promising framework to identify best practices and improve outcome after TBI. CER is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care. The purpose of CER is to assist consumers, clinicians, purchasers, and policy makers to make informed decisions that will improve health care at both the individual and population levels.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of TBI
- •Clinical indication for CT scan
- •Presentation within 24 hours of injury
- •Informed consent obtained according to local and national requirements
排除标准
- •Severe pre-existing neurological disorder that would confound outcome assessments
结局指标
主要结局
SF-12v2 Health Survey (Short-Form Health Survey With 12 Questions) at 6 Months
时间窗: 6 months
The SF-12v2 Health Survey uses 12 questions to measure functional health and well-being from the patient's point of view. The SF-12v2 at 6 months is available in 2300 patients.
Glasgow Outcome Scale - Extended (GOSE) at 6 Months
时间窗: 6 months
The Extended Glasgow Outcome Scale is a global scale for functional outcome that rates patient status into 8 categories, going from dead to good recovery. 1. Death 2. Vegetative sate 3. Lower severe disability 4. Upper severe disability 5. Lower moderate disability 6. Upper moderate disability - some disability but can potentially return to some form of employment 7. Lower good recovery - minor physical or mental defect 8. Upper good recovery - full recovery The 6-month GOSE score is available in 3804 patients (84%).
6 Month Quality of Life in Brain Injury (Qolibri-OS) <52 (Impaired)
时间窗: 6 months
The Quality of Life in Brain Injury (Qolibri-OS) is a 6 item overall scale that provides a profile of health-related quality of life in domains typicality affected by brain injury, such as physical function, cognition, emotional status, ability to perform daily activities, personal life and social relationship, and satisfaction with current situation and future prospects. The QOLIBRI scores are reported on a 0-100 scale , where 0=worst possible quality of life and 100=best possible quality of life.
次要结局
- 6 Month Galveston Orientation and Amnesia Test (GOAT) < 75 (Impaired)(6 months)
- 6 Month JK Coma Recovery Scale - Revised <23 (Impaired)(6 months)
- 6 Month Post-traumatic Stress Disorder (PTSD) Checklist for DSM-5 (PCL-5) <33 (Impaired)(6 months)
- 6 Month Rivermead Post Concussion Questionnaire <16 (Impaired)(6 months)
- 6 Month Timed up and go Test - Impaired(6 months)
- 6 Month Trail Making Test (TMT) Part A - Impaired(6 months)
- 6 Month Rey Auditory Verbal Learning Test (RAVLT) - Impaired(6 months)
- 6 Month Trail Making Test (TMT) Part B - Impaired(6 months)
- 6 Month Cambridge Neuropsychological Test Automated Battery (CANTAB) PAL (Paired Associate Learning Task) - Impaired(6 months)
- 6 Month Cambridge Neuropsychological Test Automated Battery (CANTAB) SOC (Stockings of Cambridge Task) - Impaired(6 months)
- 6 Month Cambridge Neuropsychological Test Automated Battery (CANTAB) SWM (Spatial Working Memory Task) - Impaired(6 months)
- 6 Month Cambridge Neuropsychological Test Automated Battery (CANTAB) AST (Attention Switching Task ) - Impaired(6 months)
- 6 Month Cambridge Neuropsychological Test Automated Battery (CANTAB) RTI (Reaction Time Task) - Impaired(6 months)
- 6 Month Cambridge Neuropsychological Test Automated Battery (CANTAB) RVP (Rapid Visual Information Processing Task) - Impaired(6 months)
- Early (2-3 Weeks) MRI Imaging - Traumatic Intracranial Abnormalities(Between 2-3 weeks after enrolment)
研究者
Andrew Maas
M.D., PhD, Project Coordinator CENTER-TBI
University Hospital, Antwerp