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Trial record 6 of 301 for:    Recruiting, Not yet recruiting, Available Studies | "Brain Injuries, Traumatic"

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

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ClinicalTrials.gov Identifier: NCT02004080
Recruitment Status : Recruiting
First Posted : December 6, 2013
Last Update Posted : March 19, 2015
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Brain Injuries, Traumatic Other: Intensive Care treatment

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 Design

Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: CREACTIVE - Collaborative REsearch on ACute Traumatic Brain Injury in intensiVe Care Medicine in Europe
Study Start Date : October 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
TBI admitted to ICU
Intensive Care treatment
Other: Intensive Care treatment
intensive care treatment

Outcome Measures

Primary Outcome Measures :
  1. Glasgow Outcome Scale Extendend (GOSe) [ Time Frame: 6 months ]
  2. Quality of life in Brain Injury Overall Scale (QOLIBRI-OS) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Mortality [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
TBI patients admitted to ICU for specific care

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02004080

Contact: Guido Bertolini, MD +390354535313 guido.bertolini@marionegri.it
Contact: Luana Nava +390354535313 luana.nava@marionegri.it

Ospedale Santa Maria di Loreto Recruiting
Napoli, Campania, Italy, 80100
Contact: Maurizio Postiglione, MD    081 254 274 0      
Principal Investigator: Maurizio Postiglione, MD         
Ospedale Maggiore Recruiting
Bologna, Emilia Romagan, Italy, 40131
Contact: Francesca Mengoli, MD    051 647 821 5      
Principal Investigator: Francesca Mengoli, MD         
AUSL della Romagna, Ospedale Bufalini Recruiting
Cesena, Emilia Romagna, Italy, 47023
Contact: Costanza Martino, MD    054 735 281 8      
Principal Investigator: Costanza Martino, MD         
Ospedale San Camillo Forlanini Recruiting
Roma, Lazio, Italy, 00152
Contact: Giuseppe Nardi, MD    065 870 314 7      
Principal Investigator: Giuseppe Nardi, MD         
Presidio Ospedliero di Cremon Recruiting
Cremona, Lombardia, Italy, 26100
Contact: Agata Borsella, MD    037 240 532 9      
Principal Investigator: Agata Borsella, MD         
Niguarda Cà Granda Recruiting
Milano, Lombardia, Italy, 20162
Contact: Marco Sacchi, MD    026 444 251 0      
Principal Investigator: Marco Sacchi, MD         
Ospedale A. Manzoni Recruiting
Lecco, Lombradia, Italy, 23900
Contact: Giuseppe Nattino, MD    034 148 999 3      
Principal Investigator: Giuseppe Nattino, MD         
Ospedale San Salvatore Recruiting
Pesaro, Marche, Italy, 61100
Contact: Anna De Cristofaro, MD    072 136 229 5      
Principal Investigator: Anna De Cristofaro, MD         
SS. Antonio e Biagio e C. Arrigo Recruiting
Alessandria, Piemonte, Italy, 15100
Contact: Silvia Scarrone, MD    0131206347      
Principal Investigator: Silvia Scarrone, MD         
Ospedale Edoardo Agnelli Recruiting
Pinerolo, Piemonte, Italy, 10064
Contact: Francesco Berruto, MD    0121233620      
Principal Investigator: Francesco Berruto, MD         
CTO Maria Adelaide Recruiting
Torino, Piemonte, Italy, 10126
Contact: Fulvio Agostini, MD    0116933300      
Principal Investigator: Fulvio Agostini, MD         
A.O. Universitaria Policlinico "Riuniti" Recruiting
Foggia, Puglia, Italy, 71100
Contact: Lucia Mirabella, MD    0881732387      
Principal Investigator: Lucia Mirabella, MD         
Ospedale Giovanni Paolo II Recruiting
Olbia, Sardegna, Italy, 07026
Contact: Maria Giovanna Dessena, MD    0789552984      
Principal Investigator: Maria Giovanna Dessena, MD         
AO Villa Sofia - Cervello Recruiting
Palermo, Sicilia, Italy, 90100
Contact: Baldassare Renda, MD    091 780 416 8      
Principal Investigator: Baldassare Renda, MD         
Ospedale del Mugello Recruiting
Borgo San Lorenzo, Toscana, Italy, 50032
Contact: Cecilia Bruschi, MD    055 845 130 6      
Principal Investigator: Cecilia Bruschi, MD         
AO Universitaria Careggi Recruiting
Firenze, Toscana, Italy, 50134
Contact: Alessandra De Luca, MD    055 794 841 9      
Principal Investigator: Alessandra De Luca, MD         
Ospedale di S. Chiara Recruiting
Pisa, Toscana, Italy, 56100
Contact: Malacarne Paolo, MD    050992327      
Principal Investigator: Paolo Malacarne, MD         
Ospedale di Santa Chiara Recruiting
Pisa, Toscana, Italy, 56100
Contact: Sergio Casagli, MD    050996153      
Principal Investigator: Sergio Casagli, MD         
Ospedale Santa Maria della Misericordia Recruiting
Perugia, Umbria, Italy, 06100
Contact: Adonella Gorietti, MD    075 578 389 1      
Principal Investigator: Adonella Gorietti, MD         
Ospedale Regionale della Valle d'Aosta Recruiting
Aosta, Valle d'Aosta, Italy, 11100
Contact: Massimo Gianni, MD    0165543276      
Principal Investigator: Massimo Gianni, MD         
Sponsors and Collaborators
Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
European Commission
Semmelweis University
Medical University of Warsaw
General Hospital Novo Mesto
Univerzitetni Klinikni Center Ljubljana
University of Nicosia
Ben-Gurion University of the Negev
University of Crete Medical School - University Hospital of Heraklion
Orobix Srl
Principal Investigator: Guido Bertolini, MD Istituto Di Ricerche Farmacologiche Mario Negri
More Information

Additional Information:
Responsible Party: Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
ClinicalTrials.gov Identifier: NCT02004080     History of Changes
Other Study ID Numbers: 602714
First Posted: December 6, 2013    Key Record Dates
Last Update Posted: March 19, 2015
Last Verified: March 2015

Keywords provided by Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva:
Comparative Effectiveness Research

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System