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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02004080
Other study ID # 602714
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2013
Est. completion date March 2019

Study information

Verified date March 2022
Source Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 8000
Est. completion date March 2019
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Intervention

Other:
Intensive Care treatment
intensive care treatment

Locations

Country Name City State
Italy SS. Antonio e Biagio e C. Arrigo Alessandria Piemonte
Italy Ospedale Regionale della Valle d'Aosta Aosta Valle d'Aosta
Italy Ospedale Maggiore Bologna Emilia Romagan
Italy Ospedale del Mugello Borgo San Lorenzo Toscana
Italy AUSL della Romagna, Ospedale Bufalini Cesena Emilia Romagna
Italy Presidio Ospedliero di Cremon Cremona Lombardia
Italy AO Universitaria Careggi Firenze Toscana
Italy A.O. Universitaria Policlinico "Riuniti" Foggia Puglia
Italy Ospedale A. Manzoni Lecco Lombradia
Italy Niguarda Cà Granda Milano Lombardia
Italy Ospedale Santa Maria di Loreto Napoli Campania
Italy Ospedale Giovanni Paolo II Olbia Sardegna
Italy AO Villa Sofia - Cervello Palermo Sicilia
Italy Ospedale Santa Maria della Misericordia Perugia Umbria
Italy Ospedale San Salvatore Pesaro Marche
Italy Ospedale Edoardo Agnelli Pinerolo Piemonte
Italy Ospedale di S. Chiara Pisa Toscana
Italy Ospedale di Santa Chiara Pisa Toscana
Italy Ospedale San Camillo Forlanini Roma Lazio
Italy CTO Maria Adelaide Torino Piemonte

Sponsors (10)

Lead Sponsor Collaborator
Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva Ben-Gurion University of the Negev, European Commission, General Hospital Novo Mesto, Medical University of Warsaw, Orobix Srl, Semmelweis University, University of Crete Medical School - University Hospital of Heraklion, University of Nicosia, Univerzitetni Klinikni Center Ljubljana

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Glasgow Outcome Scale Extendend (GOSe) 6 months
Primary Quality of life in Brain Injury Overall Scale (QOLIBRI-OS) 6 months
Secondary Mortality 6 months
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