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

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

Study Overview

• Status: Completed
• Conditions: Brain Injuries, Traumatic
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 8000

Contacts and Locations

Study Locations

• Italy
  • Campania
    • Napoli, Campania, Italy, 80100
      • Ospedale Santa Maria di Loreto
  • Emilia Romagan
    • Bologna, Emilia Romagan, Italy, 40131
      • Ospedale Maggiore
  • Emilia Romagna
    • Cesena, Emilia Romagna, Italy, 47023
      • AUSL della Romagna, Ospedale Bufalini
  • Lazio
    • Roma, Lazio, Italy, 00152
      • Ospedale San Camillo Forlanini
  • Lombardia
    • Cremona, Lombardia, Italy, 26100
      • Presidio Ospedliero di Cremon
    • Milano, Lombardia, Italy, 20162
      • Niguarda Cà Granda
  • Lombradia
    • Lecco, Lombradia, Italy, 23900
      • Ospedale A. Manzoni
  • Marche
    • Pesaro, Marche, Italy, 61100
      • Ospedale San Salvatore
  • Piemonte
    • Alessandria, Piemonte, Italy, 15100
      • SS. Antonio e Biagio e C. Arrigo
    • Pinerolo, Piemonte, Italy, 10064
      • Ospedale Edoardo Agnelli
    • Torino, Piemonte, Italy, 10126
      • CTO Maria Adelaide
  • Puglia
    • Foggia, Puglia, Italy, 71100
      • A.O. Universitaria Policlinico "Riuniti"
  • Sardegna
    • Olbia, Sardegna, Italy, 07026
      • Ospedale Giovanni Paolo II
  • Sicilia
    • Palermo, Sicilia, Italy, 90100
      • AO Villa Sofia - Cervello
  • Toscana
    • Borgo San Lorenzo, Toscana, Italy, 50032
      • Ospedale Del Mugello
    • Firenze, Toscana, Italy, 50134
      • AO Universitaria Careggi
    • Pisa, Toscana, Italy, 56100
      • Ospedale di S. Chiara
    • Pisa, Toscana, Italy, 56100
      • Ospedale di Santa Chiara
  • Umbria
    • Perugia, Umbria, Italy, 06100
      • Ospedale Santa Maria della Misericordia
  • Valle d'Aosta
    • Aosta, Valle d'Aosta, Italy, 11100
      • Ospedale Regionale della Valle d'Aosta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

TBI patients admitted to ICU for specific care

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Mortality	6 months

Collaborators and Investigators

• Sponsor: Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
• Collaborators: Medical University of Warsaw; European Commission; Semmelweis University; Ben-Gurion University of the Negev; University of Nicosia; General Hospital Novo Mesto; Univerzitetni Klinikni Center Ljubljana; University of Crete Medical School - University Hospital of Heraklion; Orobix Srl
• Investigators: Principal Investigator: Guido Bertolini, MD, Istituto Di Ricerche Farmacologiche Mario Negri

Publications and helpful links

Helpful Links

• Related info
• CREACTIVE website

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): March 1, 2019

Study Registration Dates

• First Submitted: December 3, 2013
• First Submitted That Met QC Criteria: December 3, 2013
• First Posted (ESTIMATE): December 6, 2013

Study Record Updates

• Last Update Posted (ACTUAL): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 15, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: ICU; TBI; Comparative Effectiveness Research
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: 602714