N/A
N=4,559
CENTER-TBI: Collaborative European NeuroTrauma Effectiveness Research in TBI
Traumatic Brain Injury
Bottom Line
View on ClinicalTrials.gov: NCT02210221 ↗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
| Outcome | Result | p-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
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.