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Trial record 1 of 1 for:    NCT02210221
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CENTER-TBI: Collaborative European NeuroTrauma Effectiveness Research in TBI (CENTER-TBI)

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ClinicalTrials.gov Identifier: NCT02210221
Recruitment Status : Active, not recruiting
First Posted : August 6, 2014
Results First Posted : September 25, 2020
Last Update Posted : January 26, 2021
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

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Traumatic Brain Injury
Enrollment 4559
Recruitment Details CENTER-TBI is an observational cohort study. Data from 4509 patients from 18 countries, collected between Dec 9, 2014, and Dec 17, 2017, are analysed in the core study: 848 (19%) patients were in the ER stratum, 1523 (34%) in the admission stratum, and 2138 (47%) in the ICU stratum.
Pre-assignment Details Of 4559 patients in the core study, 4509 patients are available for analysis.
Arm/Group Title CENTER-TBI Population
Hide Arm/Group Description Data from 4509 patients from 18 countries, collected between Dec 9, 2014, and Dec 17, 2017, were analysed in the core study and from 22 782 patients in the registry. In the core study, 848 (19%) patients were in the ER stratum, 1523 (34%) in the admission stratum, and 2138 (47%) in the ICU stratum.
Period Title: Overall Study
Started 4559
Completed 4509
Not Completed 50
Reason Not Completed
Lack of Efficacy             7
Withdrawal by Subject             43
Arm/Group Title CENTER-TBI Population
Hide Arm/Group Description Data from 4509 patients from 18 countries, collected between Dec 9, 2014, and Dec 17, 2017, were analysed in the core study.
Overall Number of Baseline Participants 4509
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 4509 participants
50
(30 to 66)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4509 participants
Female
1486
  33.0%
Male
3023
  67.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Europe Number Analyzed 4509 participants
4509
1.Primary Outcome
Title Glasgow Outcome Scale - Extended (GOSE) at 6 Months
Hide Description

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%).

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CENTER-TBI Population ER Stratum Admission Stratum ICU Stratum
Hide Arm/Group Description:
Data from 4509 patients from 18 countries, collected between Dec 9, 2014, and Dec 17, 2017, were analysed in the core study.
patients admitted to the ER
patients admitted but not to the ICU
patients admitted to the ICU
Overall Number of Participants Analyzed 3804 694 1264 1846
Measure Type: Count of Participants
Unit of Measure: Participants
6-month GOSE <8
2419
  63.6%
207
  29.8%
665
  52.6%
1547
  83.8%
6-month unfavourable outcome (GOSE <5)
966
  25.4%
31
   4.5%
140
  11.1%
795
  43.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CENTER-TBI Population
Comments null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum in 6-month mortality
Type of Statistical Test Non-Inferiority
Comments non-inferiority margin = 0
Statistical Test of Hypothesis P-Value <0.0001
Comments No corrections for multiple comparisons were done
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CENTER-TBI Population
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter observed to expected ratio
Estimated Value 0.70
Confidence Interval (2-Sided) 95%
0.62 to 0.76
Estimation Comments numerator: 6-month mortality observed denominator: 6-month mortality expected 95% CIs estimated according to a Poisson distribution
2.Primary Outcome
Title SF-12v2 Health Survey (Short-Form Health Survey With 12 Questions) at 6 Months
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CENTER-TBI Population ER Stratum Admission Stratum ICU Stratum
Hide Arm/Group Description:
Data from 4509 patients from 18 countries, collected between Dec 9, 2014, and Dec 17, 2017, were analysed in the core study.
patients in the ER
patients admitted but not to the ICU
patients admitted to the ICU
Overall Number of Participants Analyzed 2300 480 857 963
Measure Type: Count of Participants
Unit of Measure: Participants
6-month SF-12v2 mental component summary <40 (impaired)
551
  24.0%
101
  21.0%
184
  21.5%
266
  27.6%
6-month SF-12v2 physical component summary <40 (impaired)
661
  28.7%
112
  23.3%
207
  24.2%
342
  35.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CENTER-TBI Population
Comments null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum in SF-12v2 mental component summary
Type of Statistical Test Non-Inferiority
Comments non-inferiority margin = 0
Statistical Test of Hypothesis P-Value <0.0001
Comments No corrections for multiple comparisons were done
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CENTER-TBI Population
Comments null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum in SF-12v2 physical component summary
Type of Statistical Test Non-Inferiority
Comments non-inferiority margin = 0
Statistical Test of Hypothesis P-Value <0.0001
Comments No corrections for multiple comparisons were done
Method ANOVA
Comments [Not Specified]
3.Primary Outcome
Title 6 Month Quality of Life in Brain Injury (Qolibri-OS) <52 (Impaired)
Hide Description

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.

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CENTER-TBI Population ER Stratum Admission Stratum ICU Stratum
Hide Arm/Group Description:
Data from 4509 patients from 18 countries, collected between Dec 9, 2014, and Dec 17, 2017, were analysed in the core study.
patients at the ER
patients admitted but not to the ICU
patients admitted to the ICU
Overall Number of Participants Analyzed 2323 474 866 983
Measure Type: Count of Participants
Unit of Measure: Participants
511
  22.0%
91
  19.2%
160
  18.5%
260
  26.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CENTER-TBI Population
Comments null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum in Qolibri Overall Scale
Type of Statistical Test Non-Inferiority
Comments non-inferiority margin = 0
Statistical Test of Hypothesis P-Value <0.0001
Comments No corrections for multiple comparisons were done
Method ANOVA
Comments [Not Specified]
4.Secondary Outcome
Title The Post-traumatic Stress Disorder (PTSD) Checklist for DSM-5 (PCL-5)
Hide Description The project runs until December 2020 and data analyses are still ongoing. Evaluation of the secondary outcome measures are part of the ongoing analyses and will be reported at study end.
Time Frame 6 months
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Rivermead Post Concussion Questionnaire
Hide Description The project runs until December 2020 and data analyses are still ongoing. Evaluation of the secondary outcome measures are part of the ongoing analyses and will be reported at study end.
Time Frame 6 months
Outcome Measure Data Not Reported
6.Secondary Outcome
Title SF-36v2 Health Survey (Short-Form Health Survey With 36 Questions)
Hide Description The project runs until December 2020 and data analyses are still ongoing. Evaluation of the secondary outcome measures are part of the ongoing analyses and will be reported at study end.
Time Frame 6 months
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Galveston Orientation and Amnesia Test (GOAT)
Hide Description The project runs until December 2020 and data analyses are still ongoing. Evaluation of the secondary outcome measures are part of the ongoing analyses and will be reported at study end.
Time Frame 6 months
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Rey Auditory Verbal Learning Test (RAVLT)
Hide Description The project runs until December 2020 and data analyses are still ongoing. Evaluation of the secondary outcome measures are part of the ongoing analyses and will be reported at study end.
Time Frame 6 months
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Trail Making Test (TMT)
Hide Description The project runs until December 2020 and data analyses are still ongoing. Evaluation of the secondary outcome measures are part of the ongoing analyses and will be reported at study end.
Time Frame 6 months
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Cambridge Neuropsychological Test Automated Battery (CANTAB)
Hide Description The project runs until December 2020 and data analyses are still ongoing. Evaluation of the secondary outcome measures are part of the ongoing analyses and will be reported at study end.
Time Frame 6 months
Outcome Measure Data Not Reported
11.Secondary Outcome
Title 10 Meter Walk and Timed up and go Test
Hide Description The project runs until December 2020 and data analyses are still ongoing. Evaluation of the secondary outcome measures are part of the ongoing analyses and will be reported at study end.
Time Frame 6 months
Outcome Measure Data Not Reported
12.Secondary Outcome
Title JK Coma Recovery Scale - Revised
Hide Description The project runs until December 2020 and data analyses are still ongoing. Evaluation of the secondary outcome measures are part of the ongoing analyses and will be reported at study end.
Time Frame 6 months
Outcome Measure Data Not Reported
13.Secondary Outcome
Title MRI Imaging
Hide Description The project runs until December 2020 and data analyses are still ongoing. Evaluation of the secondary outcome measures are part of the ongoing analyses and will be reported at study end.
Time Frame Between 2-3 weeks after enrolment
Outcome Measure Data Not Reported
Time Frame 2 years
Adverse Event Reporting Description

Observational study: no adverse events to be reported since there is no intervention.

The number of patients admitted to the ICU is seen as the population at risk for all-cause mortality, due to the severity of ICU patients: 2138 patients.

 
Arm/Group Title CENTER-TBI Population
Hide Arm/Group Description Data from 4509 patients from 18 countries, collected between Dec 9, 2014, and Dec 17, 2017, were analysed in the core study.
All-Cause Mortality
CENTER-TBI Population
Affected / at Risk (%)
Total   363/2138 (16.98%) 
Hide Serious Adverse Events
CENTER-TBI Population
Affected / at Risk (%)
Total   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CENTER-TBI Population
Affected / at Risk (%)
Total   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Prof. Em. Dr Andrew Maas
Organization: UZA
Phone: 0032 3 821 45 37
EMail: andrew.maas@uza.be
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Andrew Maas, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT02210221    
Other Study ID Numbers: 602150
First Submitted: July 29, 2014
First Posted: August 6, 2014
Results First Submitted: April 6, 2020
Results First Posted: September 25, 2020
Last Update Posted: January 26, 2021