Clinical trial NCT02004080: CREACTIVE - Collaborative REsearch on ACute Traumatic Brain Injury in intensiVe Care Medicine in Europe
Official title: CREACTIVE - Collaborative REsearch on ACute Traumatic Brain Injury in intensiVe Care Medicine in Europe
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Injuries, Traumatic
Keywords: TBI
ICU
Comparative Effectiveness Research
Lead sponsor: Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
Sponsor class: OTHER
Collaborators: name: European Commission
name: Semmelweis University
name: Medical University of Warsaw
name: General Hospital of Novo mesto
name: Univerzitetni Klinikni Center Ljubljana
name: University of Nicosia
name: Ben-Gurion University of the Negev
name: University of Crete Medical School - University Hospital of Heraklion
name: Orobix Srl
First posted: 2013-12-06
Enrollment: 8000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: TBI patients admitted to ICU for specific care

Brief summary: CREACTIVE is a large-scale observational cohort study concerning Traumatic Brain Injury (TBI) care in the ICU setting

Detailed description: Traumatic brain injury (TBI) is among the leading causes of death and disability and the main cause of death among the under-45s. Most patients with moderate to severe TBI are admitted to intensive care units (ICUs).

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.

Eligibility criteria: Inclusion Criteria:

All patients admitted to the participating ICUs with a diagnosis of traumatic brain injury, regardless of their severity,will be recruited.

Exclusion Criteria:

Absence of Informed consent

Primary outcomes:
measure: Glasgow Outcome Scale Extendend (GOSe)
timeFrame: 6 months
measure: Quality of life in Brain Injury Overall Scale (QOLIBRI-OS)
timeFrame: 6 months
Secondary outcomes:
measure: Mortality
timeFrame: 6 months
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Ospedale Santa Maria di Loreto
state: Campania
city: Bologna
country: Italy
facility: Ospedale Maggiore
state: Emilia Romagan
city: Cesena
country: Italy
facility: AUSL della Romagna, Ospedale Bufalini
state: Emilia Romagna
city: Roma
country: Italy
facility: Ospedale San Camillo Forlanini
state: Lazio
city: Cremona
country: Italy
facility: Presidio Ospedliero di Cremon
state: Lombardia
city: Milano
country: Italy
facility: Niguarda Cà Granda
state: Lombardia
city: Lecco
country: Italy
facility: Ospedale A. Manzoni
state: Lombradia
city: Pesaro
country: Italy
facility: Ospedale San Salvatore
state: Marche
city: Alessandria
country: Italy
facility: SS. Antonio e Biagio e C. Arrigo
state: Piemonte
city: Pinerolo
country: Italy
facility: Ospedale Edoardo Agnelli
state: Piemonte
city: Torino
country: Italy
facility: CTO Maria Adelaide
state: Piemonte
city: Foggia
country: Italy
facility: A.O. Universitaria Policlinico "Riuniti"
state: Puglia
city: Olbia
country: Italy
facility: Ospedale Giovanni Paolo II
state: Sardegna
city: Palermo
country: Italy
facility: AO Villa Sofia - Cervello
state: Sicilia
city: Borgo San Lorenzo
country: Italy
facility: Ospedale del Mugello
state: Toscana
city: Firenze
country: Italy
facility: AO Universitaria Careggi
state: Toscana
city: Pisa
country: Italy
facility: Ospedale di S. Chiara
state: Toscana
city: Pisa
country: Italy
facility: Ospedale di Santa Chiara
state: Toscana
city: Perugia
country: Italy
facility: Ospedale Santa Maria della Misericordia
state: Umbria
city: Aosta
country: Italy
facility: Ospedale Regionale della Valle d'Aosta
state: Valle d'Aosta
Study officials:
affiliation: Istituto Di Ricerche Farmacologiche Mario Negri
name: Guido Bertolini, MD
role: PRINCIPAL_INVESTIGATOR
References: