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CENTER-TBI: Collaborative European NeuroTrauma Effectiveness Research in TBI (CENTER-TBI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02210221
Recruitment Status : Active, not recruiting
First Posted : August 6, 2014
Results First Posted : September 25, 2020
Last Update Posted : September 25, 2020
Sponsor:
Collaborators:
University of Cambridge
Erasmus Medical Center
San Gerardo Hospital
University of Sheffield
University of California, San Francisco
Karolinska Institutet
ICON plc
GABO:mi
icoMetrix NV, Leuven, Belgium
Information provided by (Responsible Party):
Andrew Maas, University Hospital, Antwerp

Brief Summary:

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.

Condition or disease
Traumatic Brain Injury

Show Show detailed description

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Study Type : Observational [Patient Registry]
Actual Enrollment : 4559 participants
Observational Model: Cohort
Time Perspective: Prospective
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 : December 30, 2020



Primary Outcome Measures :
  1. 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. The 6-month GOSE score is available in 3804 patients (84%).

  2. 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.

  3. Quality of Life in Brain Injury (Qolibri-OS) at 6 Months Questionnaire Overall Scale (QOLIBRI-OS) [ 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-OS at 6 months is available in 2323 patients.



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Galveston Orientation and Amnesia Test (GOAT) [ 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.

  5. Rey Auditory Verbal Learning Test (RAVLT) [ 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.

  6. Trail Making Test (TMT) [ 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.

  7. Cambridge Neuropsychological Test Automated Battery (CANTAB) [ 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.

  8. 10 Meter Walk and Timed up and go Test [ 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.

  9. JK Coma Recovery Scale - Revised [ 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.

  10. MRI Imaging [ Time Frame: Between 2-3 weeks after enrolment ]
    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.


Biospecimen Retention:   Samples With DNA
whole blood samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients presenting with traumatic brain injury.

The data collection will be stratified upon enrolment into 3 clinical groups differentiated by clinical care path:

  • ER stratum: patients seen and discharged from the ER
  • Admission stratum: patients admitted to hospital but not to the ICU
  • ICU stratum: patients admitted directly to the ICU
Criteria

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

Exclusion Criteria:

  • Severe pre-existing neurological disorder that would confound outcome assessments

Information from the National Library of Medicine

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


Locations
Show Show 65 study locations
Sponsors and Collaborators
University Hospital, Antwerp
University of Cambridge
Erasmus Medical Center
San Gerardo Hospital
University of Sheffield
University of California, San Francisco
Karolinska Institutet
ICON plc
GABO:mi
icoMetrix NV, Leuven, Belgium
Investigators
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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
  Study Documents (Full-Text)

Documents provided by Andrew Maas, University Hospital, Antwerp:
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Andrew Maas, M.D., PhD, Project Coordinator CENTER-TBI, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT02210221    
Other Study ID Numbers: 602150
First Posted: August 6, 2014    Key Record Dates
Results First Posted: September 25, 2020
Last Update Posted: September 25, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Andrew Maas, University Hospital, Antwerp:
TBI
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries