CREACTIVE - Collaborative REsearch on ACute Traumatic Brain Injury in intensiVe Care Medicine in Europe
NCT ID: NCT02004080
Last Updated: 2022-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
8000 participants
OBSERVATIONAL
2013-10-31
2019-03-31
Brief Summary
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Detailed Description
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The 'PROmoting patient SAFEty and quality improvement in critical care' ICU network was recently established in 6 European countries through European Union funding (PHEA 2007331), and has continued to collect high-quality data beyond the grant duration. In 2012, 242 ICUs had joined 'PROmoting patient SAFEty and quality improvement in critical care', recruiting a total of 85,965 patients. Of these ICUs, 180 admitted at least one TBI patient, totaling more than 3,300 cases. Hence, the network is expected to enroll 7-9,000 moderate-to-severe TBI patients in 4 years, in about 125 participating ICUs. The 'PROmoting patient SAFEty and quality improvement in critical care' consortium has already focused attention on TBI and has just started collecting additional information on this condition in order to develop a prognostic model to identify centers of excellence in TBI management. Aims of the CREACTIVE project are to consolidate the existing network in order to better describe the epidemiology of moderate-to-severe TBI in 7 countries (Cyprus, Greece, Hungary, Israel, Italy, Poland, Slovenia); establish centralized repositories of biological samples (blood and derived fluids, CSF) and clinical imaging data, to be exploit for prognostic purposes; build a prognostic model based on clinical and biological data to predict short- and long-term outcome; identify most effective clinical interventions for optimally treating TBI patients; recognize the determinants of optimal vs. suboptimal performance.
All patients admitted to the participating ICUs with a diagnosis of traumatic brain injury, regardless of their severity, will be recruited. Centralized repositories of imaging data and biological samples for the analysis of phenotypic and genotypic biomarkers will be established for approx. 2,000 adult TBI patients.
Follow-up will be performed six months after the trauma event, and will be two-tiered. The first level will be administered over the phone and constituted of the extended version of the Glasgow Outcome Scale (GOSe) and a health-related quality of care questionnaire. The second level will encompass a patient's full examination that, for children, will include a dedicated sleep disturbances study. The second level follow-up will be performed in a selected subgroup of ICUs.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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TBI admitted to ICU
Intensive Care treatment
Intensive Care treatment
intensive care treatment
Interventions
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Intensive Care treatment
intensive care treatment
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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European Commission
OTHER
Semmelweis University
OTHER
Medical University of Warsaw
OTHER
General Hospital of Novo mesto
OTHER
Univerzitetni Klinikni Center Ljubljana
UNKNOWN
University of Nicosia
OTHER
Ben-Gurion University of the Negev
OTHER
University of Crete Medical School - University Hospital of Heraklion
UNKNOWN
Orobix Srl
UNKNOWN
Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
OTHER
Responsible Party
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Principal Investigators
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Guido Bertolini, MD
Role: PRINCIPAL_INVESTIGATOR
Istituto Di Ricerche Farmacologiche Mario Negri
Locations
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Ospedale Regionale della Valle d'Aosta
Aosta, Aosta Valley, Italy
A.O. Universitaria Policlinico "Riuniti"
Foggia, Apulia, Italy
Ospedale Santa Maria di Loreto
Napoli, Campania, Italy
Ospedale Maggiore
Bologna, Emilia Romagan, Italy
AUSL della Romagna, Ospedale Bufalini
Cesena, Emilia-Romagna, Italy
Ospedale San Camillo Forlanini
Rome, Lazio, Italy
Presidio Ospedliero di Cremon
Cremona, Lombardy, Italy
Niguarda Cà Granda
Milan, Lombardy, Italy
Ospedale A. Manzoni
Lecco, Lombradia, Italy
SS. Antonio e Biagio e C. Arrigo
Alessandria, Piedmont, Italy
Ospedale Edoardo Agnelli
Pinerolo, Piedmont, Italy
CTO Maria Adelaide
Turin, Piedmont, Italy
Ospedale Giovanni Paolo II
Olbia, Sardinia, Italy
AO Villa Sofia - Cervello
Palermo, Sicily, Italy
Ospedale San Salvatore
Pesaro, The Marches, Italy
Ospedale del Mugello
Borgo San Lorenzo, Tuscany, Italy
AO Universitaria Careggi
Florence, Tuscany, Italy
Ospedale di S. Chiara
Pisa, Tuscany, Italy
Ospedale di Santa Chiara
Pisa, Tuscany, Italy
Ospedale Santa Maria della Misericordia
Perugia, Umbria, Italy
Countries
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Related Links
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Related info
CREACTIVE website
Other Identifiers
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602714
Identifier Type: -
Identifier Source: org_study_id
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