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%).
6-month GOSE <8
Group
Value
95% CI
CENTER-TBI Population
2419
ER Stratum
207
Admission Stratum
665
ICU Stratum
1547
6-month unfavourable outcome (GOSE <5)
Group
Value
95% CI
CENTER-TBI Population
966
ER Stratum
31
Admission Stratum
140
ICU Stratum
795
SF-12v2 Health Survey (Short-Form Health Survey With 12 Questions) at 6 MonthsPrimary· 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.
6 Month Quality of Life in Brain Injury (Qolibri-OS) <52 (Impaired)Primary· 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.
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.
Group
Value
95% CI
CENTER-TBI Population
201
ER Stratum
40
Admission Stratum
77
ICU Stratum
84
6 Month Rivermead Post Concussion Questionnaire <16 (Impaired)Secondary· 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
Group
Value
95% CI
CENTER-TBI Population
643
ER Stratum
98
Admission Stratum
200
ICU Stratum
345
6 Month Galveston Orientation and Amnesia Test (GOAT) < 75 (Impaired)Secondary· 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
Group
Value
95% CI
CENTER-TBI Population
67
ER Stratum
6
Admission Stratum
8
ICU Stratum
53
6 Month Rey Auditory Verbal Learning Test (RAVLT) - ImpairedSecondary· 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.
Group
Value
95% CI
CENTER-TBI Population
350
ER Stratum
45
Admission Stratum
107
ICU Stratum
198
6 Month Timed up and go Test - ImpairedSecondary· 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.
Group
Value
95% CI
CENTER-TBI Population
342
ER Stratum
62
Admission Stratum
108
ICU Stratum
172
6 Month JK Coma Recovery Scale - Revised <23 (Impaired)Secondary· 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.
Group
Value
95% CI
CENTER-TBI Population
17
ER/Admission Stratum
0
ICU Stratum
17
6 Month Trail Making Test (TMT) Part A - ImpairedSecondary· 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 sc
Group
Value
95% CI
CENTER-TBI Population
402
ER Stratum
46
Admission Stratum
134
ICU Stratum
222
6 Month Trail Making Test (TMT) Part B - ImpairedSecondary· 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 performa
Group
Value
95% CI
CENTER-TBI Population
368
ER Stratum
46
Admission Stratum
113
ICU Stratum
209
6 Month Cambridge Neuropsychological Test Automated Battery (CANTAB) PAL (Paired Associate Learning Task) - ImpairedSecondary· 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 sc
Group
Value
95% CI
CENTER-TBI Population
231
ER Stratum
42
Admission Stratum
72
ICU Stratum
117
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University Hospital, Antwerp
Last refreshed: 7 November 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02210221.