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Trial record 6 of 317 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
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva

December 3, 2013
December 6, 2013
March 19, 2015
October 2013
December 2015   (Final data collection date for primary outcome measure)
  • Glasgow Outcome Scale Extendend (GOSe) [ Time Frame: 6 months ]
  • Quality of life in Brain Injury Overall Scale (QOLIBRI-OS) [ Time Frame: 6 months ]
Disability [ Time Frame: 6 months ]
Complete list of historical versions of study NCT02004080 on ClinicalTrials.gov Archive Site
Mortality [ Time Frame: 6 months ]
Same as current
Not Provided
Not Provided
 
CREACTIVE - Collaborative REsearch on ACute Traumatic Brain Injury in intensiVe Care Medicine in Europe
CREACTIVE - Collaborative REsearch on ACute Traumatic Brain Injury in intensiVe Care Medicine in Europe
CREACTIVE is a large-scale observational cohort study concerning Traumatic Brain Injury (TBI) care in the ICU setting

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.

Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
12 Months
Not Provided
Non-Probability Sample
TBI patients admitted to ICU for specific care
Brain Injuries, Traumatic
Other: Intensive Care treatment
intensive care treatment
TBI admitted to ICU
Intensive Care treatment
Intervention: Other: Intensive Care treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10000
5000
September 2018
December 2015   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
Child, Adult, Older Adult
No
Contact: Guido Bertolini, MD +390354535313 guido.bertolini@marionegri.it
Contact: Luana Nava +390354535313 luana.nava@marionegri.it
Italy
 
 
NCT02004080
602714
No
Not Provided
Not Provided
Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
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
Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
March 2015