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NCT02210221: CENTER-TBI

CENTER-TBI: Collaborative European NeuroTrauma Effectiveness Research in TBI

Completed Results posted Last updated 7 November 2022
What this trial tests

trial in Traumatic Brain Injury in 4,559 participants. Completed in 31 March 2021.

Timeline
19 December 2014
Primary endpoint
1 September 2018
31 March 2021

Quick facts

Lead sponsorUniversity Hospital, Antwerp
StatusCompleted
Study typeOBSERVATIONAL
Enrollment4,559
Start date19 December 2014
Primary completion1 September 2018
Estimated completion31 March 2021
Sites65 locations across Italy, Finland, Denmark, Netherlands, Belgium, Sweden, Lithuania, Latvia

Conditions studied

Sponsor

University Hospital, Antwerp

Who can join

Eligibility, any sex, with Traumatic Brain Injury. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Glasgow Outcome Scale - Extended (GOSE) at 6 Months Primary · 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%).

6-month GOSE <8
GroupValue95% CI
CENTER-TBI Population2419
ER Stratum207
Admission Stratum665
ICU Stratum1547
6-month unfavourable outcome (GOSE <5)
GroupValue95% CI
CENTER-TBI Population966
ER Stratum31
Admission Stratum140
ICU Stratum795
SF-12v2 Health Survey (Short-Form Health Survey With 12 Questions) at 6 Months Primary · 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 SF-12v2 mental component summary <40 (impaired)
GroupValue95% CI
CENTER-TBI Population551
ER Stratum101
Admission Stratum184
ICU Stratum266
6-month SF-12v2 physical component summary <40 (impaired)
GroupValue95% CI
CENTER-TBI Population661
ER Stratum112
Admission Stratum207
ICU Stratum342
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.

GroupValue95% CI
CENTER-TBI Population511
ER Stratum91
Admission Stratum160
ICU Stratum260
6 Month Post-traumatic Stress Disorder (PTSD) Checklist for DSM-5 (PCL-5) <33 (Impaired) Secondary · 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.

GroupValue95% CI
CENTER-TBI Population201
ER Stratum40
Admission Stratum77
ICU Stratum84
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

GroupValue95% CI
CENTER-TBI Population643
ER Stratum98
Admission Stratum200
ICU Stratum345
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

GroupValue95% CI
CENTER-TBI Population67
ER Stratum6
Admission Stratum8
ICU Stratum53
6 Month Rey Auditory Verbal Learning Test (RAVLT) - Impaired Secondary · 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.

GroupValue95% CI
CENTER-TBI Population350
ER Stratum45
Admission Stratum107
ICU Stratum198
6 Month Timed up and go Test - Impaired Secondary · 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.

GroupValue95% CI
CENTER-TBI Population342
ER Stratum62
Admission Stratum108
ICU Stratum172
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.

GroupValue95% CI
CENTER-TBI Population17
ER/Admission Stratum0
ICU Stratum17
6 Month Trail Making Test (TMT) Part A - Impaired Secondary · 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

GroupValue95% CI
CENTER-TBI Population402
ER Stratum46
Admission Stratum134
ICU Stratum222
6 Month Trail Making Test (TMT) Part B - Impaired Secondary · 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

GroupValue95% CI
CENTER-TBI Population368
ER Stratum46
Admission Stratum113
ICU Stratum209
6 Month Cambridge Neuropsychological Test Automated Battery (CANTAB) PAL (Paired Associate Learning Task) - Impaired Secondary · 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

GroupValue95% CI
CENTER-TBI Population231
ER Stratum42
Admission Stratum72
ICU Stratum117

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):

  1. Case-mix, care pathways, and outcomes in patients with traumatic brain injury in CENTER-TBI: a European prospective, multicentre, longitudinal, cohort study.
    Steyerberg EW, Wiegers E, Sewalt C, Buki A, et al · · 2019 · cited 376× · PMID 31526754 · DOI 10.1016/s1474-4422(19)30232-7
  2. Blood biomarkers on admission in acute traumatic brain injury: Relations to severity, CT findings and care path in the CENTER-TBI study.
    Czeiter E, Amrein K, Gravesteijn BY, Lecky F, et al · · 2020 · cited 196× · PMID 32464528 · DOI 10.1016/j.ebiom.2020.102785
  3. Clinical characteristics and outcomes in patients with traumatic brain injury in China: a prospective, multicentre, longitudinal, observational study.
    Gao G, Wu X, Feng J, Hui J, et al · · 2020 · cited 137× · PMID 32702336 · DOI 10.1016/s1474-4422(20)30182-4
  4. Tracheostomy practice and timing in traumatic brain-injured patients: a CENTER-TBI study.
    Robba C, Galimberti S, Graziano F, Wiegers EJA, et al · · 2020 · cited 92× · PMID 32025780 · DOI 10.1007/s00134-020-05935-5
  5. Pathological Computed Tomography Features Associated With Adverse Outcomes After Mild Traumatic Brain Injury: A TRACK-TBI Study With External Validation in CENTER-TBI.
    Yuh EL, Jain S, Sun X, Pisica D, et al · · 2021 · cited 89× · PMID 34279565 · DOI 10.1001/jamaneurol.2021.2120
  6. Effect of frailty on 6-month outcome after traumatic brain injury: a multicentre cohort study with external validation.
    Galimberti S, Graziano F, Maas AIR, Isernia G, et al · · 2022 · cited 70× · PMID 35065038 · DOI 10.1016/s1474-4422(21)00374-4
  7. Clustering identifies endotypes of traumatic brain injury in an intensive care cohort: a CENTER-TBI study.
    Åkerlund CAI, Holst A, Stocchetti N, Steyerberg EW, et al · · 2022 · cited 67× · PMID 35897070 · DOI 10.1186/s13054-022-04079-w
  8. Occurrence and timing of withdrawal of life-sustaining measures in traumatic brain injury patients: a CENTER-TBI study.
    van Veen E, van der Jagt M, Citerio G, Stocchetti N, et al · · 2021 · cited 64× · PMID 34351445 · DOI 10.1007/s00134-021-06484-1

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