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N/A N=4,559

CENTER-TBI: Collaborative European NeuroTrauma Effectiveness Research in TBI

Traumatic Brain Injury

Enrolled (actual)
4,559
Serious AEs
Results posted
Sep 2020
Primary outcome: Primary: Glasgow Outcome Scale - Extended (GOSE) at 6 Months — 2419; 207; 665; 1547 Participants — p=<0.0001

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
Age
Pediatric, Adult, Older Adult
Sex
All
Sponsor
University Hospital, Antwerp
Primary completion
Sep 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Glasgow Outcome Scale - Extended (GOSE) at 6 Months
2419; 207; 665; 1547; 966; 31 <0.0001 sig
PRIMARY
SF-12v2 Health Survey (Short-Form Health Survey With 12 Questions) at 6 Months
551; 101; 184; 266; 661; 112 <0.0001 sig
PRIMARY
6 Month Quality of Life in Brain Injury (Qolibri-OS) <52 (Impaired)
511; 91; 160; 260 <0.0001 sig
SECONDARY
6 Month Post-traumatic Stress Disorder (PTSD) Checklist for DSM-5 (PCL-5) <33 (Impaired)
201; 40; 77; 84 <0.0001 sig
SECONDARY
6 Month Rivermead Post Concussion Questionnaire <16 (Impaired)
643; 98; 200; 345 <0.0001 sig
SECONDARY
6 Month Galveston Orientation and Amnesia Test (GOAT) < 75 (Impaired)
67; 6; 8; 53 <0.0001 sig
SECONDARY
6 Month Rey Auditory Verbal Learning Test (RAVLT) - Impaired
350; 45; 107; 198 <0.0001 sig
SECONDARY
6 Month Timed up and go Test - Impaired
342; 62; 108; 172 0.169
SECONDARY
6 Month JK Coma Recovery Scale - Revised <23 (Impaired)
17; 0; 17 <0.0001 sig
SECONDARY
6 Month Trail Making Test (TMT) Part A - Impaired
402; 46; 134; 222 <0.0001 sig
SECONDARY
6 Month Trail Making Test (TMT) Part B - Impaired
368; 46; 113; 209 <0.0001 sig
SECONDARY
6 Month Cambridge Neuropsychological Test Automated Battery (CANTAB) PAL (Paired Associate Learning Task) - Impaired
231; 42; 72; 117 0.637
SECONDARY
6 Month Cambridge Neuropsychological Test Automated Battery (CANTAB) RTI (Reaction Time Task) - Impaired
237; 38; 63; 136 <0.0001 sig
SECONDARY
6 Month Cambridge Neuropsychological Test Automated Battery (CANTAB) SWM (Spatial Working Memory Task) - Impaired
259; 49; 81; 129 0.480
SECONDARY
6 Month Cambridge Neuropsychological Test Automated Battery (CANTAB) RVP (Rapid Visual Information Processing Task) - Impaired
225; 33; 46; 146 <0.0001 sig
SECONDARY
6 Month Cambridge Neuropsychological Test Automated Battery (CANTAB) SOC (Stockings of Cambridge Task) - Impaired
182; 28; 64; 90 0.024 sig
SECONDARY
6 Month Cambridge Neuropsychological Test Automated Battery (CANTAB) AST (Attention Switching Task ) - Impaired
282; 49; 85; 148 0.064
SECONDARY
Early (2-3 Weeks) MRI Imaging - Traumatic Intracranial Abnormalities
312; 32; 101; 179 <0.0001 sig

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.

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02210221). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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