CENTER-TBI: Collaborative European NeuroTrauma Effectiveness Research in TBI
NCT ID: NCT02210221
Last Updated: 2022-11-07
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Total Enrollment
4559 participants
Study Classification
OBSERVATIONAL
Study Start Date
2014-12-19
Study Completion Date
2021-03-31
Brief Summary
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The research aims of the CENTER-TBI study are to:
1. better characterize Traumatic Brain Injury (TBI) as a disease and describe it in a European context, and
2. identify the most effective clinical interventions for managing TBI.
Specific aims
1. To collect high quality clinical and epidemiological data with repositories for neuro-imaging, DNA, and serum from patients with TBI.
2. To refine and improve outcome assessment and develop health utility indices for TBI.
3. To develop multidimensional approaches to characterisation and prediction of TBI.
4. To define patient profiles which predict efficacy of specific interventions ("Precision Medicine").
5. To develop performance indicators for quality assurance and quality improvement in TBI care.
6. 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.
7. To develop an open database compatible with Federal Interagency Traumatic Brain Injury Research (FITBIR).
8. To intensify networking activities and international collaborations in TBI.
9. 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.
10. To develop a "knowledge commons" for TBI, integrating CENTER-TBI outputs into systematic reviews.
1. better characterize Traumatic Brain Injury (TBI) as a disease and describe it in a European context, and
2. identify the most effective clinical interventions for managing TBI.
Specific aims
1. To collect high quality clinical and epidemiological data with repositories for neuro-imaging, DNA, and serum from patients with TBI.
2. To refine and improve outcome assessment and develop health utility indices for TBI.
3. To develop multidimensional approaches to characterisation and prediction of TBI.
4. To define patient profiles which predict efficacy of specific interventions ("Precision Medicine").
5. To develop performance indicators for quality assurance and quality improvement in TBI care.
6. 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.
7. To develop an open database compatible with Federal Interagency Traumatic Brain Injury Research (FITBIR).
8. To intensify networking activities and international collaborations in TBI.
9. 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.
10. To develop a "knowledge commons" for TBI, integrating CENTER-TBI outputs into systematic reviews.
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Detailed Description
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• 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.
* Cohort:
A large core cohort of patients across the severity spectrum in TBI will be recruited at approximately 77 sites in Europe and Israel (the CENTER-TBI Core Study): 5400 patients differentiated into 3 equal strata of approximately 1800:
* ER stratum: patients seen and discharged from the ER;
* Admission stratum: patients admitted to the hospital but not to the ICU;
* ICU stratum: patients admitted directly to the ICU. Balance in numbers between the strata will be aimed for, but sites will be allowed to arrange recruitment strategies to best suit their local requirements.
The core cohort will be underpinned by comparison with a larger registry (the CENTER-TBI registry) based on pragmatic data collection of all patients with TBI seen in participating centres (to establish the internal generalizability of our study), and by comparison with national trauma registries (to establish the external generalizability of our findings).
In the core cohort, detailed data will be collected on clinical parameters, neuroimaging studies, biomarker analyses, DNA analyses, and longitudinal outcome assessments. In selected centres, extended studies will additionally focus on advanced magnetic resonance (MR) imaging, detailed coagulation profiling and high resolution ICU monitoring.
* Sample size assessment:
The sample size estimate (n=5400) was based on:
* Practical logistic considerations
* Power calculations for the different strata, targeting comparative effectiveness analyses, assuming a between-centre and between-country heterogeneity as identified in previous research (expressed by variance parameter from a random effects model, Tau\^2 of 0.431)
* Postulated odds ratios for intervention effects of approximately 5% improvement in outcome.
Overall, these calculations provided a statistical power to detect odds ratios of \~1.2 associated with differences in process or intervention variables across the core dataset with a power of 80%; and require somewhat larger odds ratios in each of the three individual strata. In the registry we expect to be able to detect differences (predominantly in organizational or system variables) with an odds ratio of 1.2 with a power of 82%.
* Quality control and assurance:
Continuous monitoring of enrolment and completeness of data will be performed by ICON as contract research organization (CRO). Source data verification (SDV) will be performed in 10% of subjects by the CRO. The quality of data collection will be further enhanced by implementing automated data entry checks for impossible/implausible values and implementing data checks for consistency between variables. A task force of study personnel will evaluate the completeness, consistency and validity of submitted data and function as support desk for participating sites.
* Data management:
Prior to upload to the study database, all acquired data will be stored locally. All patients will be allocated a random Global Unique Personal Identification number (GUPI) which will be linked locally to hospital identifiers. All uploaded data will be de-identified and images will be defaced prior to upload. While blood samples and clinical data will be linked, both sets of data will be kept confidential and anonymised beyond the initial stage of correlation for analysis. All imaging and electronic data will be kept on individually password protected servers. All clinical data will be entered into electronic Case Report Forms (eCRFs) and managed by the 'QuesGen data management platform' (http://www.quesgen.com/) which will be developed in collaboration with Karolinska Institutet International Neuroinformatics Coordinating Faculty (KI-INCF). As data is entered into each form, the system will run data validation checks that include conditionally required data, validation across fields, and validation requirements based on subject type. If any validation check fails, the user is alerted immediately that the data does not meet Quality Assurance (QA) criteria and the issue can be addressed and corrected at that point. All de-identified electronic study data in the CENTER-TBI database will be stored securely in the European data space under supervision of KI-INCF for the duration of subject enrolment and follow-up and for a period afterwards for data analysis and preparation of publications. We estimate that the analysis and publication period will last for several years after the conclusion of subject enrolment.
Together with QuesGen Systems, KI-INCF will ensure that data standards are established for the data model e.g. conformity of field formats, field codes and names to ensure consistency across all datasets. Any approved changes will be fully documented with dataset updates to maintain data quality and accuracy. KI-INCF will be responsible for importing cleaned datasets to other analytic platforms as determined by the coordinators.
Where applicable, information relevant to the patient's care will be made available to the physician responsible. Data, including blood samples collected as part of this study will be shared in an anonymised form with collaborators from other European states (this is part of a European Commission Framework7 funded program), and with selected collaborators in other countries who form part of an emerging International Traumatic Brain Injury Research initiative.
* Computing platform and Neuroinformatics Resource:
The KI-INCF will coordinate the establishment of an informatics platform for acquisition, storage and analysis of CDE-based clinical data. The goal is to develop a next generation open standards-based platform to support advanced large-scale analytics and model building. Such a platform also provides a model for future clinical studies on brain diseases and disorders. This development will receive additional support from One Mind for Research.
* Statistical analysis plan:
Statistical analyses for the Comparative Effectiveness Research (CER) questions will primarily apply random effects modelling, in which center is included at the higher level, and patients are considered clustered within centers. In some analyses, higher levels of clustering will also be considered, e.g. country, or European region; or lower levels, e.g. physicians within hospitals. Confounding factors as measured at the individual patient and/or center level, will be considered extensively, and will be targeted to the specific research question.
Statistical analyses for better characterization of TBI will be exploratory, aiming to better understand the complexity of the disease and to discover new associations. In addition to standard statistical descriptive and inferential techniques, we will also employ novel machine learning techniques as appropriate.
Prognostic analyses will consider a range of variables, including genetic, demographic and clinical data, physiological signals, imaging results, and biomarkers as predictors of early endpoints and physiologic derangement (e.g. raised ICP), and late outcome, including mortality, functional outcome, quality of life and neuropsychological performance. Previously and newly developed prediction models will be validated by comparison of observed to predicted outcome risks, with predictive performance summarized by measures for model fit, discrimination, and calibration.
* Missing data:
Every effort will be made to limit the number of missing data in the CENTER-TBI study. Missing values are, however, inherent to any clinical study. Missing values may confound the descriptive, prognostic and CER analyses. Thus, appropriate techniques for dealing with missing values are required. First, we will evaluate the various reasons for missingness per centre. Next, we will explore the use of alternative statistical approaches, including inverse probability weighting and multiple imputation. We will consider missing values in baseline characteristics as well as in short and long term outcomes. Based on simulation studies and practical considerations we will develop standard operating procedures towards the analyses with missing values, respecting the differences in multiple research questions.
* Informed Consent:
Informed consent procedures will follow local and national requirements in all cases. We anticipate that many potential patients will not be able to consent themselves to participate in this project. The nature of TBI means that some patients may lack capacity to decide to participate in this study especially at the earliest time point. It is important to try and include these patients to ensure that representative samples of patients are included to avoid bias in the study findings. Every step will be taken to ensure that a test of capacity is undertaken before a decision on a person's capacity to consent or not to consent to participation in research is taken. If the subject is not capable of self-consent, all efforts will be made to locate a legally acceptable representative to act on behalf of the subject. When a legally acceptable representative (e.g. consultee/proxy) is identified, their opinion will be sought about the potential participant's wishes and feelings in relation to the project, and whether he or she would have wanted to take part in the study.
Subjects are free to withdraw, or be withdrawn by their consultee/proxy if appropriate, at any point in the study, and they need not state a reason.
* Impact:
The CENTER-TBI project will contribute towards the overall goals of InTBIR, by identifying more effective and efficient treatment provision, thus improving outcome and reducing costs. The science in the project will provide novel information on disease processes, treatment, outcome, and prognosis in TBI, identifying new therapeutic targets and therapies; while the CENTER-TBI repositories will ensure opportunities for legacy research. Thus, the project has the potential to improve current health care and its delivery at both population and individual levels, deliver early scientific advances that could improve the care of patients with TBI, and provide a rich investment for future biomedical research.
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.
* Cohort:
A large core cohort of patients across the severity spectrum in TBI will be recruited at approximately 77 sites in Europe and Israel (the CENTER-TBI Core Study): 5400 patients differentiated into 3 equal strata of approximately 1800:
* ER stratum: patients seen and discharged from the ER;
* Admission stratum: patients admitted to the hospital but not to the ICU;
* ICU stratum: patients admitted directly to the ICU. Balance in numbers between the strata will be aimed for, but sites will be allowed to arrange recruitment strategies to best suit their local requirements.
The core cohort will be underpinned by comparison with a larger registry (the CENTER-TBI registry) based on pragmatic data collection of all patients with TBI seen in participating centres (to establish the internal generalizability of our study), and by comparison with national trauma registries (to establish the external generalizability of our findings).
In the core cohort, detailed data will be collected on clinical parameters, neuroimaging studies, biomarker analyses, DNA analyses, and longitudinal outcome assessments. In selected centres, extended studies will additionally focus on advanced magnetic resonance (MR) imaging, detailed coagulation profiling and high resolution ICU monitoring.
* Sample size assessment:
The sample size estimate (n=5400) was based on:
* Practical logistic considerations
* Power calculations for the different strata, targeting comparative effectiveness analyses, assuming a between-centre and between-country heterogeneity as identified in previous research (expressed by variance parameter from a random effects model, Tau\^2 of 0.431)
* Postulated odds ratios for intervention effects of approximately 5% improvement in outcome.
Overall, these calculations provided a statistical power to detect odds ratios of \~1.2 associated with differences in process or intervention variables across the core dataset with a power of 80%; and require somewhat larger odds ratios in each of the three individual strata. In the registry we expect to be able to detect differences (predominantly in organizational or system variables) with an odds ratio of 1.2 with a power of 82%.
* Quality control and assurance:
Continuous monitoring of enrolment and completeness of data will be performed by ICON as contract research organization (CRO). Source data verification (SDV) will be performed in 10% of subjects by the CRO. The quality of data collection will be further enhanced by implementing automated data entry checks for impossible/implausible values and implementing data checks for consistency between variables. A task force of study personnel will evaluate the completeness, consistency and validity of submitted data and function as support desk for participating sites.
* Data management:
Prior to upload to the study database, all acquired data will be stored locally. All patients will be allocated a random Global Unique Personal Identification number (GUPI) which will be linked locally to hospital identifiers. All uploaded data will be de-identified and images will be defaced prior to upload. While blood samples and clinical data will be linked, both sets of data will be kept confidential and anonymised beyond the initial stage of correlation for analysis. All imaging and electronic data will be kept on individually password protected servers. All clinical data will be entered into electronic Case Report Forms (eCRFs) and managed by the 'QuesGen data management platform' (http://www.quesgen.com/) which will be developed in collaboration with Karolinska Institutet International Neuroinformatics Coordinating Faculty (KI-INCF). As data is entered into each form, the system will run data validation checks that include conditionally required data, validation across fields, and validation requirements based on subject type. If any validation check fails, the user is alerted immediately that the data does not meet Quality Assurance (QA) criteria and the issue can be addressed and corrected at that point. All de-identified electronic study data in the CENTER-TBI database will be stored securely in the European data space under supervision of KI-INCF for the duration of subject enrolment and follow-up and for a period afterwards for data analysis and preparation of publications. We estimate that the analysis and publication period will last for several years after the conclusion of subject enrolment.
Together with QuesGen Systems, KI-INCF will ensure that data standards are established for the data model e.g. conformity of field formats, field codes and names to ensure consistency across all datasets. Any approved changes will be fully documented with dataset updates to maintain data quality and accuracy. KI-INCF will be responsible for importing cleaned datasets to other analytic platforms as determined by the coordinators.
Where applicable, information relevant to the patient's care will be made available to the physician responsible. Data, including blood samples collected as part of this study will be shared in an anonymised form with collaborators from other European states (this is part of a European Commission Framework7 funded program), and with selected collaborators in other countries who form part of an emerging International Traumatic Brain Injury Research initiative.
* Computing platform and Neuroinformatics Resource:
The KI-INCF will coordinate the establishment of an informatics platform for acquisition, storage and analysis of CDE-based clinical data. The goal is to develop a next generation open standards-based platform to support advanced large-scale analytics and model building. Such a platform also provides a model for future clinical studies on brain diseases and disorders. This development will receive additional support from One Mind for Research.
* Statistical analysis plan:
Statistical analyses for the Comparative Effectiveness Research (CER) questions will primarily apply random effects modelling, in which center is included at the higher level, and patients are considered clustered within centers. In some analyses, higher levels of clustering will also be considered, e.g. country, or European region; or lower levels, e.g. physicians within hospitals. Confounding factors as measured at the individual patient and/or center level, will be considered extensively, and will be targeted to the specific research question.
Statistical analyses for better characterization of TBI will be exploratory, aiming to better understand the complexity of the disease and to discover new associations. In addition to standard statistical descriptive and inferential techniques, we will also employ novel machine learning techniques as appropriate.
Prognostic analyses will consider a range of variables, including genetic, demographic and clinical data, physiological signals, imaging results, and biomarkers as predictors of early endpoints and physiologic derangement (e.g. raised ICP), and late outcome, including mortality, functional outcome, quality of life and neuropsychological performance. Previously and newly developed prediction models will be validated by comparison of observed to predicted outcome risks, with predictive performance summarized by measures for model fit, discrimination, and calibration.
* Missing data:
Every effort will be made to limit the number of missing data in the CENTER-TBI study. Missing values are, however, inherent to any clinical study. Missing values may confound the descriptive, prognostic and CER analyses. Thus, appropriate techniques for dealing with missing values are required. First, we will evaluate the various reasons for missingness per centre. Next, we will explore the use of alternative statistical approaches, including inverse probability weighting and multiple imputation. We will consider missing values in baseline characteristics as well as in short and long term outcomes. Based on simulation studies and practical considerations we will develop standard operating procedures towards the analyses with missing values, respecting the differences in multiple research questions.
* Informed Consent:
Informed consent procedures will follow local and national requirements in all cases. We anticipate that many potential patients will not be able to consent themselves to participate in this project. The nature of TBI means that some patients may lack capacity to decide to participate in this study especially at the earliest time point. It is important to try and include these patients to ensure that representative samples of patients are included to avoid bias in the study findings. Every step will be taken to ensure that a test of capacity is undertaken before a decision on a person's capacity to consent or not to consent to participation in research is taken. If the subject is not capable of self-consent, all efforts will be made to locate a legally acceptable representative to act on behalf of the subject. When a legally acceptable representative (e.g. consultee/proxy) is identified, their opinion will be sought about the potential participant's wishes and feelings in relation to the project, and whether he or she would have wanted to take part in the study.
Subjects are free to withdraw, or be withdrawn by their consultee/proxy if appropriate, at any point in the study, and they need not state a reason.
* Impact:
The CENTER-TBI project will contribute towards the overall goals of InTBIR, by identifying more effective and efficient treatment provision, thus improving outcome and reducing costs. The science in the project will provide novel information on disease processes, treatment, outcome, and prognosis in TBI, identifying new therapeutic targets and therapies; while the CENTER-TBI repositories will ensure opportunities for legacy research. Thus, the project has the potential to improve current health care and its delivery at both population and individual levels, deliver early scientific advances that could improve the care of patients with TBI, and provide a rich investment for future biomedical research.
Conditions
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Traumatic Brain Injury
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of TBI
* Clinical indication for CT scan
* Presentation within 24 hours of injury
* Informed consent obtained according to local and national requirements
* Clinical indication for CT scan
* Presentation within 24 hours of injury
* Informed consent obtained according to local and national requirements
Exclusion Criteria
* Severe pre-existing neurological disorder that would confound outcome assessments
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Cambridge
OTHER
Sponsor Role
collaborator
Erasmus Medical Center
OTHER
Sponsor Role
collaborator
San Gerardo Hospital
OTHER
Sponsor Role
collaborator
University of Sheffield
OTHER
Sponsor Role
collaborator
University of California, San Francisco
OTHER
Sponsor Role
collaborator
Karolinska Institutet
OTHER
Sponsor Role
collaborator
ICON plc
INDUSTRY
Sponsor Role
collaborator
GABO:mi
INDUSTRY
Sponsor Role
collaborator
icometrix
INDUSTRY
Sponsor Role
collaborator
University Hospital, Antwerp
OTHER
Sponsor Role
lead
Responsible Party
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Andrew Maas
M.D., PhD, Project Coordinator CENTER-TBI
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Andrew Maas, MD, PhD
Role: STUDY_CHAIR
Antwerp University Hospital / University of Antwerp, Edegem, Belgium
David Menon, MD, PhD
Role: STUDY_DIRECTOR
University of Cambridge, Addenbrookes hospital, Cambridge, UK
Locations
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Innsbruck Medical University
Innsbruck, , Austria
Site Status
Medical University Vienna
Vienna, , Austria
Site Status
Antwerp University Hospital
Edegem, , Belgium
Site Status
University Hospitals Leuven
Leuven, , Belgium
Site Status
CHR Citadelle
Liège, , Belgium
Site Status
CHU Liege
Liège, , Belgium
Site Status
Region Hovedstaden Rigshospitalet
Copenhagen, , Denmark
Site Status
Odense University Hospital
Odense, , Denmark
Site Status
Helsinki University Central Hospital
Helsinki, , Finland
Site Status
Turku University Hospital
Turku, , Finland
Site Status
University Hospital of Grenoble
Grenoble, , France
Site Status
Lille University Hospital
Lille, , France
Site Status
University Hospital Nancy
Nancy, , France
Site Status
APHP
Paris, , France
Site Status
CHU Poitiers
Poitiers, , France
Site Status
University Hospital Aachen
Aachen, , Germany
Site Status
Charité Campus Virchow
Berlin, , Germany
Site Status
University Hospital Heidelberg
Heidelberg, , Germany
Site Status
Klinikum Ludwigsburg
Ludwigsburg, , Germany
Site Status
University of Pecs
Pécs, , Hungary
Site Status
University of Szeged
Szeged, , Hungary
Site Status
Rambam Medical Center
Haifa, , Israel
Site Status
Hadassah-hebrew University Medical Center
Jerusalem, , Israel
Site Status
Bufalini Hospital
Cesena, , Italy
Site Status
Fondazione IRCCS Cà Granda Ospedale Maggiore Poloclinico
Milan, , Italy
Site Status
Niguarda Hospital
Milan, , Italy
Site Status
S Raffaele University Hospital
Milan, , Italy
Site Status
ASST di Monza
Monza, , Italy
Site Status
Maggiore Della Carità Hospital
Novara, , Italy
Site Status
Azienda Ospedaliera Università di Padova
Padua, , Italy
Site Status
AOU Città della Salute e della Scienza di Torino
Torino, , Italy
Site Status
Rezekne Hospital
Rēzekne, , Latvia
Site Status
Pauls Stradins Clinical University Hospital
Riga, , Latvia
Site Status
Riga Eastern Clinical University Hospital
Riga, , Latvia
Site Status
University of Health Sciences
Kaunas, , Lithuania
Site Status
Center of neurovascular surgery, Clinic of neurology and neurosurgery, Vilnius University
Vilnius, , Lithuania
Site Status
Kaunas University of technology and Vilnius University
Vilnius, , Lithuania
Site Status
University Medical Center Groningen
Groningen, , Netherlands
Site Status
Leiden University Medical Center
Leiden, , Netherlands
Site Status
Radboud University Medical Center
Nijmegen, , Netherlands
Site Status
Erasmus MC
Rotterdam, , Netherlands
Site Status
Medical Center Haaglanden
The Hague, , Netherlands
Site Status
The HAGA Hospital
The Hague, , Netherlands
Site Status
TweeSteden Ziekenhuis
Tilburg, , Netherlands
Site Status
Oslo University Hospital
Oslo, , Norway
Site Status
University Hospital Northern Norway
Tromsø, , Norway
Site Status
St Olavs Hospital/Norwegian University of science and technology
Trondheim, , Norway
Site Status
Emergency County Hospital Timisoara
Timișoara, , Romania
Site Status
Clinical centre of Vojvodina
Novi Sad, , Serbia
Site Status
Vall d'Hebron University Hospital
Barcelona, , Spain
Site Status
Cruces University Hospital
Bilbao, , Spain
Site Status
Hospital Universitario 12 de Octubre
Madrid, , Spain
Site Status
Clínico Universitario de Valencia
Valencia, , Spain
Site Status
Karolinska University Hospital
Stockholm, , Sweden
Site Status
Umea University Hospital
Umeå, , Sweden
Site Status
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Site Status
Queen Elizabeth Hospital
Birmingham, , United Kingdom
Site Status
Southmead Hospital
Bristol, , United Kingdom
Site Status
Addenbrookes Hospital
Cambridge, , United Kingdom
Site Status
Lothian Health Board
Edinburgh, , United Kingdom
Site Status
The Walton centre NHS Foundation Trust
Liverpool, , United Kingdom
Site Status
Kings college London
London, , United Kingdom
Site Status
Salford Royal Hospital
Salford, , United Kingdom
Site Status
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, , United Kingdom
Site Status
University Hospitals Southampton NHS Trust
Southampton, , United Kingdom
Site Status
Countries
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Austria
Belgium
Denmark
Finland
France
Germany
Hungary
Israel
Italy
Latvia
Lithuania
Netherlands
Norway
Romania
Serbia
Spain
Sweden
Switzerland
United Kingdom
References
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Jacob L, Castro J, Heslot C, Andelic N, Tenovuo O; CENTER-TBI Participants and Investigators (Appendix); Azouvi P. Absence from work in the 12 months following mild traumatic brain injury in Europe: a CENTER-TBI cohort study. Ann Phys Rehabil Med. 2025 Sep 30;68(8):102017. doi: 10.1016/j.rehab.2025.102017. Online ahead of print.
Reference Type
DERIVED
Kals M, Wilson L, Levey DF, Parodi L, Steyerberg EW, Richardson S, He F, Sun X, Jain S, Palotie A, Ripatti S, Rosand J, Manley GT, Maas AIR, Stein MB, Menon DK; Genetic Associations In Neurotrauma (GAIN) Consortium (with contribution from the CENTER-TBI and TRACK-TBI studies). Genetic vulnerability and adverse mental health outcomes following mild traumatic brain injury: a meta-analysis of CENTER-TBI and TRACK-TBI cohorts. EClinicalMedicine. 2024 Dec 5;78:102956. doi: 10.1016/j.eclinm.2024.102956. eCollection 2024 Dec.
Reference Type
DERIVED
Guglielmi A, Graziano F, Bogossian EG, Turgeon AF, Taccone FS, Citerio G; CENTER-TBI Participants and Investigators. Haemoglobin values, transfusion practices, and long-term outcomes in critically ill patients with traumatic brain injury: a secondary analysis of CENTER-TBI. Crit Care. 2024 Jun 14;28(1):199. doi: 10.1186/s13054-024-04980-6.
Reference Type
DERIVED
Pisica D, Volovici V, Yue JK, van Essen TA, den Boogert HF, Vande Vyvere T, Haitsma I, Nieboer D, Markowitz AJ, Yuh EL, Steyerberg EW, Peul WC, Dirven CMF, Menon DK, Manley GT, Maas AIR, Lingsma HF; CENTER-TBI Participants and Investigators. Clinical and Imaging Characteristics, Care Pathways, and Outcomes of Traumatic Epidural Hematomas: A Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury Study. Neurosurgery. 2024 Nov 1;95(5):986-999. doi: 10.1227/neu.0000000000002982. Epub 2024 May 21.
Reference Type
DERIVED
Vreeburg RJG, Singh RD, van Erp IAM, Korhonen TK, Yue JK, Mee H, Timofeev I, Kolias A, Helmy A, Depreitere B, Moojen WA, Younsi A, Hutchinson P, Manley GT, Steyerberg EW, de Ruiter GCW, Maas AIR, Peul WC, van Dijck JTJM, den Boogert HF, Posti JP, van Essen TA; for the CENTER-TBI Participants and Investigators. Early versus delayed cranioplasty after decompressive craniectomy in traumatic brain injury: a multicenter observational study within CENTER-TBI and Net-QuRe. J Neurosurg. 2024 Apr 26;141(4):895-907. doi: 10.3171/2024.1.JNS232172. Print 2024 Oct 1.
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DERIVED
Howe EI, Andelic N, Brunborg C, Zeldovich M, Helseth E, Skandsen T, Olsen A, Fure SCR, Theadom A, Rauen K, Madsen BA, Jacobs B, van der Naalt J, Tartaglia MC, Einarsen CE, Storvig G, Tronvik E, Tverdal C, von Steinbuchel N, Roe C, Hellstrom T; CENTER-TBI Participants and Investigators. Frequency and predictors of headache in the first 12 months after traumatic brain injury: results from CENTER-TBI. J Headache Pain. 2024 Mar 25;25(1):44. doi: 10.1186/s10194-024-01751-0.
Reference Type
DERIVED
Zeldovich M, Bockhop F, Covic A, Mueller I, Polinder S, Mikolic A, van der Vlegel M, von Steinbuechel N; CENTER-TBI participants and investigators. Factorial validity and comparability of the six translations of the Rivermead Post-Concussion Symptoms Questionnaire translations: results from the CENTER-TBI study. J Patient Rep Outcomes. 2023 Sep 8;7(1):90. doi: 10.1186/s41687-023-00632-5.
Reference Type
DERIVED
van Essen TA, van Erp IAM, Lingsma HF, Pisica D, Yue JK, Singh RD, van Dijck JTJM, Volovici V, Younsi A, Kolias A, Peppel LD, Heijenbrok-Kal M, Ribbers GM, Menon DK, Hutchinson PJA, Manley GT, Depreitere B, Steyerberg EW, Maas AIR, de Ruiter GCW, Peul WC; CENTER-TBI Investigators and Participants. Comparative effectiveness of decompressive craniectomy versus craniotomy for traumatic acute subdural hematoma (CENTER-TBI): an observational cohort study. EClinicalMedicine. 2023 Aug 9;63:102161. doi: 10.1016/j.eclinm.2023.102161. eCollection 2023 Sep.
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DERIVED
Lang L, Wang T, Xie L, Yang C, Skudder-Hill L, Jiang J, Gao G, Feng J. An independently validated nomogram for individualised estimation of short-term mortality risk among patients with severe traumatic brain injury: a modelling analysis of the CENTER-TBI China Registry Study. EClinicalMedicine. 2023 Apr 28;59:101975. doi: 10.1016/j.eclinm.2023.101975. eCollection 2023 May.
Reference Type
DERIVED
Howe EI, Zeldovich M, Andelic N, von Steinbuechel N, Fure SCR, Borgen IMH, Forslund MV, Hellstrom T, Soberg HL, Sveen U, Rasmussen M, Kleffelgaard I, Tverdal C, Helseth E, Lovstad M, Lu J, Arango-Lasprilla JC, Tenovuo O, Azouvi P, Dawes H, Roe C; CENTER-TBI participants and investigators. Rehabilitation and outcomes after complicated vs uncomplicated mild TBI: results from the CENTER-TBI study. BMC Health Serv Res. 2022 Dec 16;22(1):1536. doi: 10.1186/s12913-022-08908-0.
Reference Type
DERIVED
Rezoagli E, Petrosino M, Rebora P, Menon DK, Mondello S, Cooper DJ, Maas AIR, Wiegers EJA, Galimberti S, Citerio G; CENTER-TBI, OzENTER-TBI Participants and Investigators. High arterial oxygen levels and supplemental oxygen administration in traumatic brain injury: insights from CENTER-TBI and OzENTER-TBI. Intensive Care Med. 2022 Dec;48(12):1709-1725. doi: 10.1007/s00134-022-06884-x. Epub 2022 Oct 20.
Reference Type
DERIVED
Akerlund CAI, Holst A, Stocchetti N, Steyerberg EW, Menon DK, Ercole A, Nelson DW; CENTER-TBI Participants and Investigators. Clustering identifies endotypes of traumatic brain injury in an intensive care cohort: a CENTER-TBI study. Crit Care. 2022 Jul 27;26(1):228. doi: 10.1186/s13054-022-04079-w.
Reference Type
DERIVED
Volovici V, Pisica D, Gravesteijn BY, Dirven CMF, Steyerberg EW, Ercole A, Stocchetti N, Nelson D, Menon DK, Citerio G, van der Jagt M, Maas AIR, Haitsma IK, Lingsma HF; CENTER-TBI investigators, participants for the ICU stratum. Comparative effectiveness of intracranial hypertension management guided by ventricular versus intraparenchymal pressure monitoring: a CENTER-TBI study. Acta Neurochir (Wien). 2022 Jul;164(7):1693-1705. doi: 10.1007/s00701-022-05257-z. Epub 2022 Jun 1.
Reference Type
DERIVED
van Essen TA, Lingsma HF, Pisica D, Singh RD, Volovici V, den Boogert HF, Younsi A, Peppel LD, Heijenbrok-Kal MH, Ribbers GM, Walchenbach R, Menon DK, Hutchinson P, Depreitere B, Steyerberg EW, Maas AIR, de Ruiter GCW, Peul WC; CENTER-TBI Collaboration Group. Surgery versus conservative treatment for traumatic acute subdural haematoma: a prospective, multicentre, observational, comparative effectiveness study. Lancet Neurol. 2022 Jul;21(7):620-631. doi: 10.1016/S1474-4422(22)00166-1. Epub 2022 May 5.
Reference Type
DERIVED
Holthe IL, Dahl HM, Rohrer-Baumgartner N, Eichler S, Elseth MF, Holthe O, Berntsen T, Yeates KO, Andelic N, Lovstad M. Neuropsychological Impairment, Brain Injury Symptoms, and Health-Related Quality of Life After Pediatric TBI in Oslo. Front Neurol. 2022 Jan 28;12:719915. doi: 10.3389/fneur.2021.719915. eCollection 2021.
Reference Type
DERIVED
Huijben JA, Pisica D, Ceyisakar I, Stocchetti N, Citerio G, Maas AIR, Steyerberg EW, Menon DK, van der Jagt M, Lingsma HF. Pharmaceutical Venous Thrombosis Prophylaxis in Critically Ill Traumatic Brain Injury Patients. Neurotrauma Rep. 2022 Jan 7;2(1):4-14. doi: 10.1089/neur.2021.0037. eCollection 2022.
Reference Type
DERIVED
Galimberti S, Graziano F, Maas AIR, Isernia G, Lecky F, Jain S, Sun X, Gardner RC, Taylor SR, Markowitz AJ, Manley GT, Valsecchi MG, Bellelli G, Citerio G; CENTER-TBI and TRACK-TBI participants and investigators. Effect of frailty on 6-month outcome after traumatic brain injury: a multicentre cohort study with external validation. Lancet Neurol. 2022 Feb;21(2):153-162. doi: 10.1016/S1474-4422(21)00374-4.
Reference Type
DERIVED
Puybasset L, Perlbarg V, Unrug J, Cassereau D, Galanaud D, Torkomian G, Battisti V, Lefort M, Velly L, Degos V, Citerio G, Bayen E, Pelegrini-Issac M; MRI-COMA Investigators CENTER-TBI MRI Participants and MRI Only Investigators. Prognostic value of global deep white matter DTI metrics for 1-year outcome prediction in ICU traumatic brain injury patients: an MRI-COMA and CENTER-TBI combined study. Intensive Care Med. 2022 Feb;48(2):201-212. doi: 10.1007/s00134-021-06583-z. Epub 2022 Dec 14.
Reference Type
DERIVED
Citerio G, Robba C, Rebora P, Petrosino M, Rossi E, Malgeri L, Stocchetti N, Galimberti S, Menon DK; Center-TBI participants and investigators. Management of arterial partial pressure of carbon dioxide in the first week after traumatic brain injury: results from the CENTER-TBI study. Intensive Care Med. 2021 Sep;47(9):961-973. doi: 10.1007/s00134-021-06470-7. Epub 2021 Jul 24.
Reference Type
DERIVED
Robba C, Rebora P, Meyfroidt G, Citerio G. The authors reply. Crit Care Med. 2021 May 1;49(5):e554-e555. doi: 10.1097/CCM.0000000000004961. No abstract available.
Reference Type
DERIVED
Huijben JA, Dixit A, Stocchetti N, Maas AIR, Lingsma HF, van der Jagt M, Nelson D, Citerio G, Wilson L, Menon DK, Ercole A; CENTER-TBI investigators and participants. Use and impact of high intensity treatments in patients with traumatic brain injury across Europe: a CENTER-TBI analysis. Crit Care. 2021 Feb 23;25(1):78. doi: 10.1186/s13054-020-03370-y.
Reference Type
DERIVED
Borgen IMH, Roe C, Brunborg C, Tenovuo O, Azouvi P, Dawes H, Majdan M, Ranta J, Rusnak M, Wiegers EJA, Tverdal C, Jacob L, Cogne M, von Steinbuechel N, Andelic N; CENTER-TBI participants investigators. Care transitions in the first 6months following traumatic brain injury: Lessons from the CENTER-TBI study. Ann Phys Rehabil Med. 2021 Nov;64(6):101458. doi: 10.1016/j.rehab.2020.10.009. Epub 2021 Jul 23.
Reference Type
DERIVED
Robba C, Banzato E, Rebora P, Iaquaniello C, Huang CY, Wiegers EJA, Meyfroidt G, Citerio G; Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI) ICU Participants and Investigators. Acute Kidney Injury in Traumatic Brain Injury Patients: Results From the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury Study. Crit Care Med. 2021 Jan 1;49(1):112-126. doi: 10.1097/CCM.0000000000004673.
Reference Type
DERIVED
Gravesteijn BY, Sewalt CA, Nieboer D, Menon DK, Maas A, Lecky F, Klimek M, Lingsma HF; CENTER-TBI collaborators. Tracheal intubation in traumatic brain injury: a multicentre prospective observational study. Br J Anaesth. 2020 Oct;125(4):505-517. doi: 10.1016/j.bja.2020.05.067. Epub 2020 Jul 31.
Reference Type
DERIVED
Gao G, Wu X, Feng J, Hui J, Mao Q, Lecky F, Lingsma H, Maas AIR, Jiang J; China CENTER-TBI Registry Participants. Clinical characteristics and outcomes in patients with traumatic brain injury in China: a prospective, multicentre, longitudinal, observational study. Lancet Neurol. 2020 Aug;19(8):670-677. doi: 10.1016/S1474-4422(20)30182-4.
Reference Type
DERIVED
Robba C, Rebora P, Banzato E, Wiegers EJA, Stocchetti N, Menon DK, Citerio G; Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury Participants and Investigators. Incidence, Risk Factors, and Effects on Outcome of Ventilator-Associated Pneumonia in Patients With Traumatic Brain Injury: Analysis of a Large, Multicenter, Prospective, Observational Longitudinal Study. Chest. 2020 Dec;158(6):2292-2303. doi: 10.1016/j.chest.2020.06.064. Epub 2020 Jul 4.
Reference Type
DERIVED
Riemann L, Beqiri E, Smielewski P, Czosnyka M, Stocchetti N, Sakowitz O, Zweckberger K, Unterberg A, Younsi A; CENTER-TBI High Resolution ICU (HR ICU) Sub-Study Participants and Investigators. Low-resolution pressure reactivity index and its derived optimal cerebral perfusion pressure in adult traumatic brain injury: a CENTER-TBI study. Crit Care. 2020 May 26;24(1):266. doi: 10.1186/s13054-020-02974-8.
Reference Type
DERIVED
Gravesteijn BY, Nieboer D, Ercole A, Lingsma HF, Nelson D, van Calster B, Steyerberg EW; CENTER-TBI collaborators. Machine learning algorithms performed no better than regression models for prognostication in traumatic brain injury. J Clin Epidemiol. 2020 Jun;122:95-107. doi: 10.1016/j.jclinepi.2020.03.005. Epub 2020 Mar 20.
Reference Type
DERIVED
Huijben JA, Wiegers EJA, Ercole A, de Keizer NF, Maas AIR, Steyerberg EW, Citerio G, Wilson L, Polinder S, Nieboer D, Menon D, Lingsma HF, van der Jagt M; CENTER-TBI investigators and participants for the ICU stratum. Quality indicators for patients with traumatic brain injury in European intensive care units: a CENTER-TBI study. Crit Care. 2020 Mar 4;24(1):78. doi: 10.1186/s13054-020-2791-0.
Reference Type
DERIVED
Van Essen TA, Volovici V, Cnossen MC, Kolias A, Ceyisakar I, Nieboer D, Peppel LD, Heijenbrok-Kal M, Ribbers G, Menon D, Hutchinson P, Depreitere B, de Ruiter GCW, Lingsma HF, Steyerberg EW, Maas AI, Peul WC. Comparative effectiveness of surgery in traumatic acute subdural and intracerebral haematoma: study protocol for a prospective observational study within CENTER-TBI and Net-QuRe. BMJ Open. 2019 Oct 16;9(10):e033513. doi: 10.1136/bmjopen-2019-033513.
Reference Type
DERIVED
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.
Reference Type
DERIVED
Maas AI, Menon DK, Steyerberg EW, Citerio G, Lecky F, Manley GT, Hill S, Legrand V, Sorgner A; CENTER-TBI Participants and Investigators. Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI): a prospective longitudinal observational study. Neurosurgery. 2015 Jan;76(1):67-80. doi: 10.1227/NEU.0000000000000575.
Reference Type
DERIVED
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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https://www.center-tbi.eu/
CENTER - TBI website
Other Identifiers
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602150
Identifier Type: -
Identifier Source: org_study_id
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