CREACTIVE - Collaborative REsearch on ACute Traumatic Brain Injury in intensiVe Care Medicine in Europe

Completed

• Conditions: Brain Injuries, Traumatic
• Interventions: Other: Intensive Care treatment

• Registration Number: NCT02004080
• Lead Sponsor: Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva

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.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-12-03
• Study First Submitted QC: 2013-12-03
• Study First Posted: 2013-12-06
• Primary Completion: 2015-12
• Study Completion: 2019-03
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-15
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TBI admitted to ICU	Intensive Care treatment	Intensive Care treatment

Primary Outcome Measures

Name	Time	Method
Glasgow Outcome Scale Extendend (GOSe)	6 months
Quality of life in Brain Injury Overall Scale (QOLIBRI-OS)	6 months

Secondary Outcome Measures

Name	Time	Method
Mortality	6 months

Trial Locations

Locations (20)

Ospedale Maggiore; 🇮🇹 Bologna, Emilia Romagan, Italy

Ospedale San Camillo Forlanini; 🇮🇹 Roma, Lazio, Italy

Ospedale Giovanni Paolo II; 🇮🇹 Olbia, Sardegna, Italy

Ospedale Santa Maria di Loreto; 🇮🇹 Napoli, Campania, Italy

Ospedale A. Manzoni; 🇮🇹 Lecco, Lombradia, Italy

AO Villa Sofia - Cervello; 🇮🇹 Palermo, Sicilia, Italy

Ospedale Santa Maria della Misericordia; 🇮🇹 Perugia, Umbria, Italy

Presidio Ospedliero di Cremon; 🇮🇹 Cremona, Lombardia, Italy

Ospedale Edoardo Agnelli; 🇮🇹 Pinerolo, Piemonte, Italy

A.O. Universitaria Policlinico "Riuniti"; 🇮🇹 Foggia, Puglia, Italy

Ospedale del Mugello; 🇮🇹 Borgo San Lorenzo, Toscana, Italy

Ospedale di S. Chiara; 🇮🇹 Pisa, Toscana, Italy

SS. Antonio e Biagio e C. Arrigo; 🇮🇹 Alessandria, Piemonte, Italy

AO Universitaria Careggi; 🇮🇹 Firenze, Toscana, Italy

Ospedale di Santa Chiara; 🇮🇹 Pisa, Toscana, Italy

Ospedale Regionale della Valle d'Aosta; 🇮🇹 Aosta, Valle d'Aosta, Italy

Ospedale San Salvatore; 🇮🇹 Pesaro, Marche, Italy

AUSL della Romagna, Ospedale Bufalini; 🇮🇹 Cesena, Emilia Romagna, Italy

Niguarda Cà Granda; 🇮🇹 Milano, Lombardia, Italy

CTO Maria Adelaide; 🇮🇹 Torino, Piemonte, Italy