Is defined as an alteration in brain function, or other evidence of brain pathology, caused by an external force . It is a leading cause of death and disability and the main cause of death among the under-45s. TBI can be classified into mild, moderate, and severe, based on assessment of the level of coma, loss or alteration of consciousness, duration of post-traumatic amnesia, and neuroimaging results . While mild TBI patients are variably managed in the different health services, most moderate and almost all severe TBI patients who manage to reach a hospital are admitted to an intensive care unit (ICU). Although these patients represent only 20% of the total, they carry the main burden of the disease. Some permanent disability is estimated to occur in 10% of mild, 66% of moderate, and 100% of severe TBIs [3-5]. Estimated in-hospital mortality is <5% in mild TBI, while it increases to 21% in moderate, and 46% in severe cases at six months . Hence, the ICU is in an ideal position to adequately evaluate and monitor the bulk of the burden of the disease, identify and assess the most effective clinical interventions, and recognize excellence in TBI management. Moreover, even mild TBI patients can be admitted to ICUs in cases of accompanying conditions (polytrauma, organ failure, important comorbidity, etc.). Through EU funding (PHEA 2007331), an ICU consortium named PROSAFE was recently established in Europe. It is currently formed by centres in six Member States (Cyprus, Greece, Hungary, Italy, Poland and Slovenia) and one Associated country (Israel), which collect high quality data on all critically ill patients admitted to the ICU . Its mission is to promote patient safety and quality of care improvement with a view to significantly reducing observed mortality rates, complications and severe disability. The Consortium is coordinated by GiViTI (Italian Group for the Evaluation of Interventions in Intensive Care Medicine), whose experience in collaborative research [8-16] dates back to 1991. The PROSAFE consortium is symbolised by the daisy (composed of a Core and Petals). The Consortium collects a core data set on all critically ill patients but the software is designed to add “Petals”, or data subsets, to the Core. The consortium has developed one such petal for TBI patients, known as the “CREACTIVE” petal, and started data collection in a subgroup of ICUs in March 2014. The resulting CREACTIVE network expects to recruit at least 7,000 and up to approx 9,000 moderate to severe TBI patients over a period of 4 years. A yearly updated prognostic model on TBI patients will be developed for the CREACTIVE petal, to be used as a benchmark for quality of care assessment in individual ICUs [17, 18]. This model is essential to be able to infer on the effectiveness of interventions from nonrandomized studies . It stems from the need to adjust for differences in severity between patients receiving or not receiving any specific intervention in everyday practice. In the clinical setting, the importance of counting on reliable measures of patient prognosis and predisposition to complications is becoming increasingly recognized, especially in acute conditions, where decisions have to be taken quickly and often in the presence of a limited number of elements. Little is known in the field of TBI in this respect. Accordingly, the CREACTIVE Consortium will set up a dedicated repository to collect and analyze biological specimens from a large, highly representative sample of TBI patients recruited to this study. We will benefit from the consolidated expertise in the field available at the coordinating Institute (in biochemical and genetic biomarkers) [20-25]. Another repository will be implemented for the collection of anonymized clinical imaging data from a representative subset of patients recruited to the study. The software utilized to upload, anonymize and analyse the clinical imaging data will be developed by the partner OROBIX as part of the CREACTIVE project.
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