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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 : Completed
First Posted : August 6, 2014
Results First Posted : September 25, 2020
Last Update Posted : November 7, 2022
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
Actual Study Completion Date : March 31, 2021



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.

    1. Death
    2. Vegetative sate
    3. Lower severe disability
    4. Upper severe disability
    5. Lower moderate disability
    6. Upper moderate disability - some disability but can potentially return to some form of employment
    7. Lower good recovery - minor physical or mental defect
    8. Upper good recovery - full 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. 6 Month Quality of Life in Brain Injury (Qolibri-OS) <52 (Impaired) [ 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 scores are reported on a 0-100 scale , where 0=worst possible quality of life and 100=best possible quality of life.



Secondary Outcome Measures :
  1. 6 Month Post-traumatic Stress Disorder (PTSD) Checklist for DSM-5 (PCL-5) <33 (Impaired) [ Time Frame: 6 months ]
    The PCL-5 is a self-report rating scale intended to assess 20 DSM-5 symptoms of Posttraumatic Stress Disorder. The standard recall period for the PCL-5 is one month. For CENTER-TBI a recall period of one week was used at the 2-3 week assessment, and the standard one month recall period was used at other time points. The sum of scores can range from 0 to 80, where high scores indicate more pronounced PTSD symptoms.

  2. 6 Month Rivermead Post Concussion Questionnaire <16 (Impaired) [ Time Frame: 6 months ]
    The Rivermead PCS Questionnaire (RPQ) was originally developed as a measure of severity of symptoms following MTBI. It consists of 16 post-concussion symptoms including headaches, dizziness, nausea/vomiting, noise sensitivity, sleep disturbance, fatigue, irritability, feeling depressed/tearful, feeling frustrated/ impatient, forgetfulness, poor concentration, taking longer to think, blurred vision, light sensitivity, double vision and restlessness. In the original version of the RPQ, participants are asked to rate the degree (on a scale of 0 to 4) to which a particular symptom has been absent or a mild, moderate or severe problem over the previous 7 days compared with premorbid levels. Total scores range from 0 to 64 with higher scores indicating more severe symptoms. Scores equal to or greater than 16 were considered indicative of persisting post-concussion symptoms.

  3. 6 Month Galveston Orientation and Amnesia Test (GOAT) < 75 (Impaired) [ Time Frame: 6 months ]

    The GOAT is a standardised assessment used to determine whether a participant is in post-traumatic amnesia (PTA). PTA is an early phase of TBI recovery during which the person with injury shows markedly impaired memory, confusion, fluctuation in performance, disorientation, and other neurobehavioral signs and symptoms. GOAT questions assess orientation, memory for the first event that the participant can recall after the injury, and memory for the last event that the participant can recall from before the injury.

    The GOAT's total score must be achieved by subtracting from 100 the total amount of error scores (Total score = 100 - total amount of error scores). Scores lower than 75 point to the fact that the victim is still experiencing amnesia.


  4. 6 Month Rey Auditory Verbal Learning Test (RAVLT) - Impaired [ Time Frame: 6 months ]

    The Rey Auditory Verbal Learning Test (RAVLT) is a test of verbal memory that assesses the ability to acquire 15 words. Recall is assessed after each presentation of the list, after the recall of an interference list, and again following a 20-minute delay. The total score for recall of the principal list ranges from 0 to 75, with higher scores indicating better performance.

    Impairment was defined as performance that was 1.33 SDs below the mean of a reference group of healthy peers.


  5. 6 Month Timed up and go Test - Impaired [ Time Frame: 6 months ]
    In the timed up and go (TUG) test, subjects are asked to rise from a standard armchair, walk to a marker 3 m away, turn, walk back, and sit down again, for quantifying functional mobility. The presence of slowness, hesitancy, abnormal trunk or arm movements, staggering or stumbling is used to grade the patient from 1 (normal) to 5 (severely abnormal). Impaired mobility was defined as taking 14 seconds or longer to perform the TUG test.

  6. 6 Month JK Coma Recovery Scale - Revised <23 (Impaired) [ Time Frame: 6 months ]
    The Coma Recovery Scale- Revised (CRS-R) is a standardized behavioral assessment instrument designed to measure neurobehavioral function in patients with disorders of consciousness (DOC). The CRS-R is comprised of six subscales addressing auditory, visual, motor, oromotor/verbal, communication and arousal functions. Subscale items are hierarchically-arranged, corresponding to brain stem, subcortical and cortically-mediated functions. Scores range between 0 (deep coma) and 23 (able to follow commands and to use objects purposefully). A total score less than 23 indicates impairment.

  7. 6 Month Trail Making Test (TMT) Part A - Impaired [ Time Frame: 6 months ]

    The Trail Making Test (TMT) is a measure of attention, speed, and mental flexibility. Part A requires the individual to draw lines to connect 25 encircled numbers distributed on a page. Part B is similar except the person must alternate between numbers and letters and is more difficult and takes longer to complete. Both sections are timed and the score represents the amount of time required to complete the task, with shorter times indicating better performance. The maximum time allowed is 100 seconds.

    Impairment cutoff: > 55.9 (based on the comparison group as a whole and expressed as raw score).

    For all the cognitive tests impairment was defined as performance that was 1.33 SDs below the mean of a reference group of healthy peers. Raw scores indicating impaired performance could be > or < than the mean depending on the test (eg. on tests of accuracy the cut-off will be a score 1.33 SDs below the mean, while on a timed test the cut-off will be 1.33 SDs above the mean).


  8. 6 Month Trail Making Test (TMT) Part B - Impaired [ Time Frame: 6 months ]

    The TMT is a measure of attention, speed, and mental flexibility. Part A requires the individual to draw lines to connect 25 encircled numbers distributed on a page. Part B is similar except the person must alternate between numbers and letters, is more difficult, takes longer to complete. Both sections are timed, the score represents the amount of time required to complete the task, with shorter times indicating better performance.

    Impairment cutoff: > 143.7 (based on the comparison group as a whole and expressed as raw score).

    For all the cognitive tests impairment was defined as performance that was 1.33 SDs below the mean of a reference group of healthy peers. Raw scores indicating impaired performance could be > or < than the mean depending on the test (eg. on tests of accuracy the cut-off will be a score 1.33 SDs below the mean, while on a timed test the cut-off will be 1.33 SDs above the mean).


  9. 6 Month Cambridge Neuropsychological Test Automated Battery (CANTAB) PAL (Paired Associate Learning Task) - Impaired [ Time Frame: 6 months ]

    CANTAB is a computerized neuropsychological battery examining a range of domains including attention, memory and executive functioning. Using mainly nonverbal stimuli, the test is language- and culture-independent. For CANTAB PAL, the individual must remember 1 to 8 patterns displayed in different positions on the screen. The score is the number of incorrect responses adjusted if necessary for trials that have not been completed. Scores ranged from 0-194 with lower score indicating better performance.

    Impairment cutoff: > 72.3 (based on the comparison group as a whole and expressed as raw score).

    For all the cognitive tests impairment was defined as performance that was 1.33 SDs below the mean of a reference group of healthy peers. Raw scores indicating impaired performance could be > or < than the mean depending on the test (eg. on tests of accuracy the cut-off will be a score 1.33 SDs below the mean, while on a timed test the cut-off will be 1.33 SDs above the mean).


  10. 6 Month Cambridge Neuropsychological Test Automated Battery (CANTAB) RTI (Reaction Time Task) - Impaired [ Time Frame: 6 months ]

    The CANTAB is a computerized neuropsychological battery examining a range of domains including attention, memory and executive functioning. Using mainly nonverbal stimuli, the test is language- and culture-independent. For CANTAB RTI, the individual must respond as quickly as possible to a circle presented at one of 5 positions. The outcome measure is the median time for correct responses (ms).

    Impairment cutoff: > 470.9 (based on the comparison group as a whole and expressed as raw score).

    For all the cognitive tests impairment was defined as performance that was 1.33 SDs below the mean of a reference group of healthy peers. Raw scores indicating impaired performance could be > or < than the mean depending on the test (eg. on tests of accuracy the cut-off will be a score 1.33 SDs below the mean, while on a timed test the cut-off will be 1.33 SDs above the mean).


  11. 6 Month Cambridge Neuropsychological Test Automated Battery (CANTAB) SWM (Spatial Working Memory Task) - Impaired [ Time Frame: 6 months ]

    The CANTAB is a computerized neuropsychological battery examining a range of domains including attention, memory and executive functioning. Using mainly nonverbal stimuli, the test is language- and culture-independent. For the CANTAB SWM, the participant searches for tokens in boxes on the screen. The between errors measure is the number of times the participant queries a box that has already been searched. Errors ranged from 0 to 151, with lower numbers indicating better performance.

    Impairment cutoff: > 52.0 (based on the comparison group as a whole and expressed as raw score).

    For all the cognitive tests impairment was defined as performance that was 1.33 SDs below the mean of a reference group of healthy peers. Raw scores indicating impaired performance could be > or < than the mean depending on the test (eg. on tests of accuracy the cut-off will be a score 1.33 SDs below the mean, while on a timed test the cut-off will be 1.33 SDs above the mean).


  12. 6 Month Cambridge Neuropsychological Test Automated Battery (CANTAB) RVP (Rapid Visual Information Processing Task) - Impaired [ Time Frame: 6 months ]

    The CANTAB is a computerized neuropsychological battery examining a range of domains including attention, memory and executive functioning. Using mainly nonverbal stimuli, the test is language- and culture-independent. For the CANTAB RVP, sequences of numbers must be detected as they appear on the screen. The measure of accuracy is A' (A prime) which is derived from hits and correct rejections. The maximum score is 1 and, a higher A' indicates better performance.

    Impairment cutoff: < 0.82 (based on the comparison group as a whole and expressed as raw score).

    For all the cognitive tests impairment was defined as performance that was 1.33 SDs below the mean of a reference group of healthy peers. Raw scores indicating impaired performance could be > or < than the mean depending on the test (eg. on tests of accuracy the cut-off will be a score 1.33 SDs below the mean, while on a timed test the cut-off will be 1.33 SDs above the mean).


  13. 6 Month Cambridge Neuropsychological Test Automated Battery (CANTAB) SOC (Stockings of Cambridge Task) - Impaired [ Time Frame: 6 months ]

    The CANTAB is a computerized neuropsychological battery examining a range of domains including attention, memory and executive functioning. Using mainly nonverbal stimuli, the test is language- and culture-independent. For the CANTAB SOC, the individual moves circles to match a target in this task based on the Tower of Hanoi game. The score is the number of problems solved in the minimum number of moves, with a maximum of 12. Higher scores indicate better performance.

    Impairment cutoff: < 5.7(based on the comparison group as a whole and expressed as raw score).

    For all the cognitive tests impairment was defined as performance that was 1.33 SDs below the mean of a reference group of healthy peers. Raw scores indicating impaired performance could be > or < than the mean depending on the test (eg. on tests of accuracy the cut-off will be a score 1.33 SDs below the mean, while on a timed test the cut-off will be 1.33 SDs above the mean).


  14. 6 Month Cambridge Neuropsychological Test Automated Battery (CANTAB) AST (Attention Switching Task ) - Impaired [ Time Frame: 6 months ]

    The CANTAB is a computerized neuropsychological battery examining a range of domains including attention, memory and executive functioning. Using mainly nonverbal stimuli, the test is language- and culture-independent. For the CANTAB AST, participants respond either to the position of an arrow or the direction it is pointing, after being cued to the task on each trial. Total correct responses range from 0 to 160, where higher numbers indicate better performance.

    Impairment cutoff: <135.5 (based on the comparison group as a whole and expressed as raw score).

    For all the cognitive tests impairment was defined as performance that was 1.33 SDs below the mean of a reference group of healthy peers. Raw scores indicating impaired performance could be > or < than the mean depending on the test (eg. on tests of accuracy the cut-off will be a score 1.33 SDs below the mean, while on a timed test the cut-off will be 1.33 SDs above the mean).


  15. Early (2-3 Weeks) MRI Imaging - Traumatic Intracranial Abnormalities [ Time Frame: Between 2-3 weeks after enrolment ]

    A selected number of sites performed MRI follow up in a subset of patients that consented for imaging data collection. The CENTER-TBI MR protocols included a high-resolution 3D T1-weighted, a T2-weighted, a FLAIR, a DTI, a T2* sequence (gradient echo and/or SWI), and (optionally) a resting-state fMRI. Across all stratum the MRI sites performed a follow up MRI at 2-3 weeks after injury.

    Traumatic Intracranial Abnormalities were assessed according to the TBI-Common Data Elements (CDEs). It indicates whether any of the 12 following imaging abnormalities are present (Mass lesion, Extra-axial Hematoma, Epidural Hematoma, Subdural Hematoma Acute, Subdural Hematoma Subacute Chronic, Subdural Collection Mixed Density, Contusion, TAI, traumatic Subarachnoid Hemorrhage, Intraventricular Hemorrhage, Midline Shift or Cisternal Compression.



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.


Layout table for eligibility information
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
Layout table for investigator information
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: November 7, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Andrew Maas, University Hospital, Antwerp:
TBI
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries