CENTER-TBI: Collaborative European NeuroTrauma Effectiveness Research in TBI (CENTER-TBI)
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|ClinicalTrials.gov Identifier: NCT02210221|
Recruitment Status : Active, not recruiting
First Posted : August 6, 2014
Results First Posted : September 25, 2020
Last Update Posted : January 26, 2021
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.
- 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.
|Condition or disease|
|Traumatic Brain Injury|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||4559 participants|
|Target Follow-Up Duration:||6 Months|
|Official Title:||Collaborative European NeuroTrauma Effectiveness Research in TBI (CENTER-TBI)|
|Actual Study Start Date :||December 19, 2014|
|Actual Primary Completion Date :||September 1, 2018|
|Estimated Study Completion Date :||March 31, 2021|
- Glasgow Outcome Scale - Extended (GOSE) at 6 Months [ Time Frame: 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.
- Vegetative sate
- Lower severe disability
- Upper severe disability
- Lower moderate disability
- Upper moderate disability - some disability but can potentially return to some form of employment
- Lower good recovery - minor physical or mental defect
- Upper good recovery - full recovery
The 6-month GOSE score is available in 3804 patients (84%).
- SF-12v2 Health Survey (Short-Form Health Survey With 12 Questions) at 6 Months [ Time Frame: 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.
- 6 Month Quality of Life in Brain Injury (Qolibri-OS) <52 (Impaired) [ Time Frame: 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.
- The Post-traumatic Stress Disorder (PTSD) Checklist for DSM-5 (PCL-5) [ Time Frame: 6 months ]The project runs until December 2020 and data analyses are still ongoing. Evaluation of the secondary outcome measures are part of the ongoing analyses and will be reported at study end.
- Rivermead Post Concussion Questionnaire [ Time Frame: 6 months ]The project runs until December 2020 and data analyses are still ongoing. Evaluation of the secondary outcome measures are part of the ongoing analyses and will be reported at study end.
- SF-36v2 Health Survey (Short-Form Health Survey With 36 Questions) [ Time Frame: 6 months ]The project runs until December 2020 and data analyses are still ongoing. Evaluation of the secondary outcome measures are part of the ongoing analyses and will be reported at study end.
- Galveston Orientation and Amnesia Test (GOAT) [ Time Frame: 6 months ]
- Rey Auditory Verbal Learning Test (RAVLT) [ Time Frame: 6 months ]
- Trail Making Test (TMT) [ Time Frame: 6 months ]
- Cambridge Neuropsychological Test Automated Battery (CANTAB) [ Time Frame: 6 months ]
- 10 Meter Walk and Timed up and go Test [ Time Frame: 6 months ]
- JK Coma Recovery Scale - Revised [ Time Frame: 6 months ]
- MRI Imaging [ Time Frame: Between 2-3 weeks after enrolment ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02210221
|Study Chair:||Andrew Maas, MD, PhD||Antwerp University Hospital / University of Antwerp, Edegem, Belgium|
|Study Director:||David Menon, MD, PhD||University of Cambridge, Addenbrookes hospital, Cambridge, UK|