CENTER-TBI: Collaborative European NeuroTrauma Effectiveness Research in TBI

NCT02210221 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 4559

Last updated 2022-11-07

Study results available
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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.

Conditions

Sponsors & Collaborators

Principal Investigators

  • Andrew Maas, MD, PhD · Antwerp University Hospital / University of Antwerp, Edegem, Belgium

  • David Menon, MD, PhD · University of Cambridge, Addenbrookes hospital, Cambridge, UK

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-19
Primary Completion
2018-09-01
Completion
2021-03-31

Countries

  • Austria
  • Belgium
  • Denmark
  • Finland
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Norway
  • Romania
  • Serbia
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02210221 on ClinicalTrials.gov