February(25th,(2015( - LUCA... · METHODOLOGY) 2.2.(CENTERTBIF( CoreData! Outcome! 13! Timepoint)...
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February 25 th , 2015 L.U.C.A. Meeting
Transcript of February(25th,(2015( - LUCA... · METHODOLOGY) 2.2.(CENTERTBIF( CoreData! Outcome! 13! Timepoint)...
February 25th, 2015 L.U.C.A. Meeting
INTRODUCTION Trauma&c Brain Injury (TBI) ! Major cause of death and disability
! Curent classification is suboptimal
! Guidelines are availables ! Management is based on weak evidence
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INTRODUCTION Context ! European Commission supports CENTER-‐TBI Project
Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury
o In interactions with other international studies (InTBIR community)
o In collaboration with the US project (TRACK-‐TBI)
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INTRODUCTION Global aims ! Identify the most effective clinical interventions
! Refine characterization of TBI, with inclusion of emerging technologies
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METHODOLOGY Mul¢er study ! 80 centers -‐ 20 countries
! Coordination o U Antwerp & U Cambridge
! Recruitment o 2 years o Since january 2015
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METHODOLOGY 1. Center Profiling ! Before to start the project
! Goal -‐ Provide a european overview
! 11 questionnaires Structure e.g.: beds number, volume, equipment, location,… Process e.g.: policies, guidelines, management strategies,…
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METHODOLOGY 1. Center Profiling
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Questionnaires Topics
General e.g. equipment, staffing
Medical Ethics e.g. IRB approval, informed consent
Prehospital e.g. dispatch systems, EMS
Emergency Department e.g. CT scan policy, discharge
Admission e.g. observation
ICU – general e.g. ICU structure, staffing
ICU – treatment e.g. ICP monitoring, treatment protocols
ICU – ethics e.g. withdrawal of life support
Neurosurgery e.g. surgical management
Rehabilitation e.g. in-‐hospital rehabilitation
Country e.g. insurance, payment
METHODOLOGY 2. Pa&ent Data
INCLUSION EXCLUSION
2.1. CENTER-‐TBI -‐ Registry (N = 15.-‐ 25.000) All ages, with diagnostic of TBI
None Indication for CT Scan
2.2. CENTER-‐TBI -‐ Core Data Study (N = 5.400) All ages, with diagnostic of TBI
Severe pre-‐existing neurological disorder
Indication for CT Scan
Presentation < 24h after injury
Informed consent obtained
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METHODOLOGY 2. Pa&ent Data ! Observational study
o No treatment injection
! 2.1. CENTER-‐TBI -‐ Registry (N = 15.-‐25.000)
! 2.2. CENTER-‐TBI -‐ Core Data Study (N = 5.400) 3 strata: Emergency -‐ Ward -‐ ICU Maximum: 100 patients/stratum
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METHODOLOGY 2.2. CENTER-‐TBI -‐ Core Data ! Clinical and physiological data
! Biomarkers, DNA
! Outcome
! Neuroimaging
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METHODOLOGY 2.2. CENTER-‐TBI -‐ Core Data ! Clinical and physiological data
o Age, gender, race,… o Education, employment, living situation,… o Medical history and medications,… o Mechanism of injury, location,… o Injury Severity Score (ISS),… o Brain CT report,… o Vital signs, GCS, fluids, labs, toxicology,…
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METHODOLOGY 2.2. CENTER-‐TBI -‐ Core Data ! Biomarkers and DNA
o Possible roles: o Diagnostic o Evolution of the pathology o Long-‐term evolution prediction of the patient state
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METHODOLOGY 2.2. CENTER-‐TBI -‐ Core Data ! Outcome
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Time point
Adm
presenta/on
Day 1
(24 + 8 hrs)
Day 3 Day 4 Day 5 Week 2-‐3 3 months 6 months 12 months 24 months
Groupe Urgences: 1800
Outcome
Neuropsych† 600 (CANTAB) 1200*** 1150
QuesGonnaires 1400 1300*** 1250
Follow up 77% 72% 64% Groupe Admission: 1800
Outcome
Neuropsych† 1200*** 300 (MR only)
250 (MR)
QuesGonnaires 1450 1300*** 1200 (non MR)
250
Follow up 81% 72% 67% Groupe USI: 1800
Outcome
Neuropsych† 1200*** 300 (MR) only)
250 (MR)
QuesGonnaires 1450 1300*** 1200 250
Follow up 81% 72% 67%
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Clinical data, neuroimaging, genomics, biomarkers, clinical & pa&ent assessed outcomes
Sub-‐studies (N~200-‐400) HR ICU MR EEG ECoG Coag
Core data (n~5400)
Study Registry (n ~20,000)
NaGonal/Regional Registries (e.g.TARN)
InternaGonal comparisons (EU, USA, Canada, Australie, Chine)
METHODOLOGY 3. CENTER-‐TBI -‐ Sub-‐studies ! MRI Data Collection
CONCLUSION
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https://www.center-‐tbi.eu
