Clinical Trial Details

NCT ID: NCT02210221
Date Last Changed: July 26, 2017

Overview

Research Study Summary

A clinical trial to evaluate treatments for patients with Traumatic Brain Injury (TBI)

Research Study Title

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

Purpose

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.

To Learn more

Recruitment Details

Gender
All
Age
N/A
Overall Status
Recruiting
Lead Sponsor
University Hospital, Antwerp
Duration
38 Months
Facility Type
N/A
Compensation

Eligibility

All ages up to N/A

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

Site Locations (52)

Country State City Zip Facility and Contact
Austria Innsbruck Innsbruck Medical University
Raimund Helbok
Austria Vienna Medical University Vienna
Elisabeth Schwendenwein
Belgium Antwerp Antwerp University Hospital
Andrew Maas
Belgium Leuven University Hospitals Leuven
Bart Depreitere
Belgium Liege CHU Liege
Steven Laureys
Denmark Odense Odense University Hospital
Christina Rosenlund
Finland Helsinki Helsinki University Central Hospital
Anna Piippo
Finland Turku Turku University Hospital
Olly Tenovuo
France Paris APHP
Louis Puybasset
Germany Aachen University Hospital Aachen
Rolf Rossaint
Germany Berlin Charité Campus Virchow
Peter Vajkoczy, MD
Germany Heidelberg University Hospital Heidelberg
Alexander Younsi
Germany Ludwigsburg Klinikum Ludwigsburg
Oliver Sakowitz
Hungary Pecs University of Pecs
Endre Czeiter
Hungary Szeged University of Szeged
Pal Barzo, MD
Israel Haifa Rambam Medical Center
Menashe Zaaroor
Israel Jerusalem Hadassah-hebrew University Medical Center
Guy Rosenthal, MD
Italy Cesena Bufalini Hospital
Costanza Martino
Italy Milan Fondazione IRCCS Cà Granda Ospedale Maggiore Poloclinico
Nino Stocchetti
Italy Milan Niguarda Hospital
Arturo Chieregato
Italy Milan S Raffaele University Hospital
Luigi Beretta
Italy Monza ASST di Monza
Giuseppe Citerio
Italy Novara Maggiore Della Carità Hospital
Francesco Della Corte
Italy Padova Azienda Ospedaliera Università di Padova
Sandra Rossi
Italy Torino AOU Città della Salute e della Scienza di Torino
Maurizio Berardino
Latvia Rezekne Rezekne Hospital
Malinka Rambadagalla
Latvia Riga Pauls Stradins Clinical University Hospital
Egils Valeinis
Latvia Riga Riga Eastern Clinical University Hospital
Kaspars Auslands
Lithuania Kaunas University of Health Sciences
Rimantas Vilcinis
Lithuania Vilnius Center of neurovascular surgery, Clinic of neurology and neurosurgery, Vilnius University
Saulius Rocka
Lithuania Vilnius Kaunas University of technology and Vilnius University
Saulius Rocka
Netherlands Groningen University Medical Center Groningen
Joukje van der Naalt
Netherlands Leiden Leiden University Medical Center
Wilco Peul
Netherlands Nijmegen Radboud University Medical Center
Ronald Bartels
Netherlands The Hague Medical Center Haaglanden
Wilco Peul
Netherlands The Hague The HAGA Hospital
Jeroen van Dijck
Netherlands Tilburg TweeSteden Ziekenhuis
Guus Schoonman
Norway Tromso University Hospital Northern Norway
Shirin Frisvold
Romania Timisoara Emergency County Hospital Timisoara
Horia Ples
Serbia Novi Sad Clinical centre of Vojvodina
Petar Vulekovic
Spain Bilbao Cruces University Hospital
Inigo Pomposo
Spain Madrid Hospital Universitario 12 de Octubre
Alfonso Lagares
Sweden Stockholm Karolinska University Hospital
Bo-Michael Bellander
Sweden Umea Umea University Hospital
Lars-Owe Koskinen
United Kingdom Birmingham Queen Elizabeth Hospital
Antonio Belli
United Kingdom Cambridge Addenbrookes Hospital
David Menon
United Kingdom Edinburgh Lothian Health Board
Jonathan Rhodes
United Kingdom Liverpool The Walton centre NHS Foundation Trust
Catherine Harris
United Kingdom London Kings college London
Christos Tolias
United Kingdom Salford Salford Royal Hospital
Fiona Lecky
United Kingdom Sheffield Sheffield Teaching Hospitals NHS Foundation Trust
George Eapen
United Kingdom Southampton University Hospitals Southampton NHS Trust
Roger Lightfoot

Contact

Andrew IR Maas, MD, PhD
+ 32 3 821 46 32

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