Trial record 8 of 28 for:    neurology AND university of california, san francisco | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by University Hospital, Antwerp
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
ClinicalTrials.gov Identifier:
NCT02210221
First received: July 29, 2014
Last updated: March 23, 2016
Last verified: March 2016
  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.

Condition
Traumatic Brain Injury

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Collaborative European NeuroTrauma Effectiveness Research in TBI (CENTER-TBI)

Resource links provided by NLM:


Further study details as provided by University Hospital, Antwerp:

Primary Outcome Measures:
  • Glasgow Outcome Scale - Extended (GOSE) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    Cross-sectional analyses will be performed in all strata (ER stratum, Admission stratum and ICU stratum) at 6 months after injury and longitudinal at various time points in the three strata up to 24 months after injury. This will additionally permit evaluation of changes over time.

    Time points per stratum:

    • ER stratum: 2-3 weeks, 3 months and 6 months;
    • Admission stratum: 3 months, 6 months, 12 months, and 24 months;
    • ICU stratum: 3 months, 6 months, 12 months and 24 months;

  • SF-12v2 Health Survey (Short-Form Health Survey with 12 questions) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    Cross-sectional analyses will be performed in all strata (ER stratum, Admission stratum and ICU stratum) at 6 months after injury and longitudinal at various time points in the three strata up to 24 months after injury. This will permit additional evaluation of changes over time.

    Time points per stratum:

    • ER stratum: 2-3 weeks, 3 months and 6 months;
    • Admission stratum: 3 months, 6 months, 12 months, and 24 months;
    • ICU stratum: 3 months, 6 months, 12 months and 24 months;

  • Quality of Life in Brain Injury Questionnaire Overall Scale (QOLIBRI-OS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    Cross-sectional analyses will be performed in all strata (ER stratum, Admission stratum and ICU stratum) at 6 months after injury and longitudinal at various time points in the three strata up to 24 months after injury. This will additionally permit evaluation of changes over time.

    Time points per stratum:

    • ER stratum: 2-3 weeks, 3 months and 6 months;
    • Admission stratum: 3 months, 6 months, 12 months, and 24 months;
    • ICU stratum: 3 months, 6 months, 12 months and 24 months;


Secondary Outcome Measures:
  • Quality of Life in Brain Injury Questionnaire (QOLIBRI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    Evaluation will be performed in all strata (ER stratum, Admission stratum and ICU stratum) at 6 months after injury and longitudinal at various time points in the three strata up to 24 months after injury. This will additionally permit evaluation of changes over time.

    Timepoints per stratum:

    • ER stratum: 2-3 weeks, 3 months and 6 months;
    • Admission stratum: 3 months, 6 months, 12 months, and 24 months;
    • ICU stratum: 3 months, 6 months, 12 months and 24 months;

  • The Post-traumatic Stress Disorder (PTSD) Checklist for DSM-5 (PCL-5) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    Evaluation will be performed in all strata (ER stratum, Admission stratum and ICU stratum) at 6 months after injury and longitudinal at various time points in the three strata up to 24 months after injury. This will additionally permit evaluation of changes over time.

    Time points per stratum:

    • ER stratum: 2-3 weeks, 3 months and 6 months;
    • Admission stratum: 3 months, 6 months, 12 months, and 24 months;
    • ICU stratum: 3 months, 6 months, 12 months and 24 months;

  • Rivermead Post Concussion Questionnaire [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    Evaluation will be performed in all strata (ER stratum, Admission stratum and ICU stratum) at 6 months after injury and longitudinal at various time points in the three strata up to 24 months after injury. This will additionally permit evaluation of changes over time.

    Time points per stratum:

    • ER stratum: 2-3 weeks, 3 months and 6 months;
    • Admission stratum: 3 months, 6 months, 12 months, and 24 months;
    • ICU stratum: 3 months, 6 months, 12 months and 24 months;

  • SF-36v2 Health Survey (Short-Form Health Survey with 36 questions) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    Evaluation will be performed in all strata (ER stratum, Admission stratum and ICU stratum) at 6 months after injury and longitudinal at various time points in the three strata up to 24 months after injury. This will additionally permit evaluation of changes over time.

    Time points per stratum:

    • ER stratum: 2-3 weeks, 3 months and 6 months;
    • Admission stratum: 3 months, 6 months, 12 months, and 24 months;
    • ICU stratum: 3 months, 6 months, 12 months and 24 months;

  • Galveston Orientation and Amnesia Test (GOAT) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    A pre-specified neuropsychological evaluation will be performed in all strata (ER stratum, Admission stratum and ICU stratum) at 6 months after injury and longitudinal at various time points in the three strata up to 24 months after injury.This will additionally permit evaluation of changes over time.

    Time points per stratum:

    • ER stratum: 2-3 weeks, 3 months and 6 months;
    • Admission stratum: 6 months, 12 months, and 24 months;
    • ICU stratum: 6 months, 12 months and 24 months;

  • Rey Auditory Verbal Learning Test (RAVLT) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    A pre-specified neuropsychological evaluation will be performed in all strata (ER stratum, Admission stratum and ICU stratum) at 6 months after injury and longitudinal at various time points in the three strata up to 24 months after injury. This will additionally permit evaluation of changes over time.

    Time points per stratum:

    • ER stratum: 2-3 weeks, 3 months and 6 months;
    • Admission stratum: 6 months, 12 months, and 24 months;
    • ICU stratum: 6 months, 12 months and 24 months;

  • Trail Making Test (TMT) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    A pre-specified neuropsychological evaluation will be performed in all strata (ER stratum, Admission stratum and ICU stratum) at 6 months after injury and longitudinal at various time points in the three strata up to 24 months after injury. This will additionally permit evaluation of changes over time.

    Time points per stratum:

    • ER stratum: 2-3 weeks, 3 months and 6 months;
    • Admission stratum: 6 months, 12 months, and 24 months;
    • ICU stratum: 6 months, 12 months and 24 months;

  • Cambridge Neuropsychological Test Automated Battery (CANTAB) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    A pre-specified neuropsychological evaluation will be performed in all strata (ER stratum, Admission stratum and ICU stratum) at 6 months after injury and longitudinal at various time points in the three strata up to 24 months after injury. This will additionally permit evaluation of changes over time.

    Time points per stratum:

    • ER stratum: 2-3 weeks, 3 months and 6 months;
    • Admission stratum: 6 months, 12 months, and 24 months;
    • ICU stratum: 6 months, 12 months and 24 months;

  • 10 meter walk and timed up and go test [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    A pre-specified neuropsychological evaluation will be performed in all strata (ER stratum, Admission stratum and ICU stratum) at 6 months after injury and longitudinal at various time points in the three strata up to 24 months after injury. This will additionally permit evaluation of changes over time.

    Time points per stratum:

    • ER stratum: 2-3 weeks, 3 months and 6 months;
    • Admission stratum: 6 months, 12 months, and 24 months;
    • ICU stratum: 6 months, 12 months and 24 months;

  • JK Coma Recovery Scale - Revised [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    Condition: in untestable patients only (GOAT<66)

    A pre-specified neuropsychological evaluation will be performed in all strata (ER stratum, Admission stratum and ICU stratum) at 6 months after injury and longitudinal at various time points in the three strata up to 24 months after injury. This will additionally permit evaluation of changes over time.

    Time points per stratum:

    • ER stratum: 2-3 weeks, 3 months and 6 months;
    • Admission stratum: 6 months, 12 months, and 24 months;
    • ICU stratum: 6 months, 12 months and 24 months;

  • MRI imaging [ Time Frame: Between 2-3 weeks after enrolment ] [ Designated as safety issue: No ]

    Centre's participating in the MR data collection arm will undertake MR scans of the brain locally, using a 3 Tesla scanning, some sites will also undertake ultra-early MR scans (<72 hours post TBI).

    The imaging protocols will be standardized as much as possible and central quality control of uploaded images will be performed by Icometrix. Standardization between centers will be further enhanced by the use of phantoms and by studying nine healthy control subjects per site.

    MRI time points per stratum:

    ER stratum

    • 200 patients: within 72 hours
    • 600 patients: 2-3 weeks
    • 250 patients: 3 months

    Admission stratum

    • 200 patients: <72 hours
    • 600 patients: 2-3 weeks
    • 600 patients: 6 months
    • 300 patients: 12 months
    • 150 patients: 24 months

    ICU stratum

    • 200 patients: <72 hours
    • 600 patients: 2-3 weeks
    • 600 patients: 6 months
    • 300 patients: 12 months
    • 150 patients: 24 months


Biospecimen Retention:   Samples With DNA
whole blood samples

Estimated Enrollment: 5400
Study Start Date: October 2014
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02210221

Contacts
Contact: Andrew IR Maas, MD, PhD + 32 3 821 46 32

  Show 63 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
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
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andrew Maas, M.D., PhD, Project Coordinator CENTER-TBI, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT02210221     History of Changes
Other Study ID Numbers: 602150 
Study First Received: July 29, 2014
Last Updated: March 23, 2016
Health Authority: Belgium: Ethics Committee

Keywords provided by University Hospital, Antwerp:
TBI

ClinicalTrials.gov processed this record on April 27, 2016