CENTER-TBI UK

• Research type

  Research Study

• Full title

  Collaborative European NeuroTrauma Effectiveness Research in TBI: a prospective longitudinal observational study

• IRAS ID

  150943

• Contact name

  Jonathan Coles

• Contact email

  jpc44@wbic.cam.ac.uk

• Sponsor organisation

  Cambridge University Hospitals NHS Foundation Trust and University of Cambridge

• Clinicaltrials.gov Identifier

  NCT02210221

• Clinicaltrials.gov Identifier

  150943, NIHR Clinical Research Network Portfolio

• Duration of Study in the UK

  6 years, 0 months, 1 days

• Research summary

  CENTER-TBI is a European Union funded observational study that aims to improve the care of patients suffering from Traumatic Brain Injury (TBI). There are many reasons why this is necessary:

  •The number of people who experience TBI is very high (approximately 2.5 million people per year in Europe alone)
  •TBI is associated with high levels of death and disability and causes great personal suffering to victims and relatives
  •The evidence on which current treatment methods are based is now outdated
  •Treatments are not standardised and vary according to where patients are treated

  The CENTER-TBI project consists of many parts: a core study, a registry and numerous work packages to help us address the lack of evidence and improve TBI care. This submission refers to the core study. In the core study we aim to recruit 5400 TBI patients (across 80 centres in 21 countries) from different places throughout acute hospitals; the emergency department, in-patient wards and intensive care.

  If the patient or relative consents, we will collect data, blood samples, and at some sites perform a non-invasive scan of the brain (MRI scan) and ask to contact the patient to follow them up (for up to 2 years). Not all patients with TBI will be eligible; we will only recruit those who present to the hospital within 24 hours of getting a TBI which is severe enough to require assessment by Computed Tomography (CT) scan as part of routine care.

  Follow-up will include questionnaires, repeat MRI scans (if done), blood samples and computer based tests of cognitive processes (CANTAB).

  Registry: Patients that are not recruited will be included in the registry part of the study. Basic clinical and treatment information will be collected without consent so that we can be sure the answers we generate about best treatment, can be generalised. A CAG application relates to this aspect of data collection in CENTER TBI.
  

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  14/SC/1370

• Date of REC Opinion

  22 Dec 2014

• REC opinion

  Further Information Favourable Opinion