CREACTIVE - Collaborative REsearch on ACute Traumatic Brain Injury in intensiVe Care Medicine in Europe
CREACTIVE
1 other identifier
observational
8,000
1 country
20
Brief Summary
CREACTIVE is a large-scale observational cohort study concerning Traumatic Brain Injury (TBI) care in the ICU setting
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2013
Longer than P75 for all trials
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 3, 2013
CompletedFirst Posted
Study publicly available on registry
December 6, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedMarch 31, 2022
March 1, 2022
2.2 years
December 3, 2013
March 15, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Glasgow Outcome Scale Extendend (GOSe)
6 months
Quality of life in Brain Injury Overall Scale (QOLIBRI-OS)
6 months
Secondary Outcomes (1)
Mortality
6 months
Study Arms (1)
TBI admitted to ICU
Intensive Care treatment
Interventions
Eligibility Criteria
TBI patients admitted to ICU for specific care
You may qualify if:
- All patients admitted to the participating ICUs with a diagnosis of traumatic brain injury, regardless of their severity,will be recruited.
You may not qualify if:
- Absence of Informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensivalead
- European Commissioncollaborator
- Semmelweis Universitycollaborator
- Medical University of Warsawcollaborator
- General Hospital of Novo mestocollaborator
- Univerzitetni Klinikni Center Ljubljanacollaborator
- University of Nicosiacollaborator
- Ben-Gurion University of the Negevcollaborator
- University of Crete Medical School - University Hospital of Heraklioncollaborator
- Orobix Srlcollaborator
Study Sites (20)
Ospedale Regionale della Valle d'Aosta
Aosta, Aosta Valley, 11100, Italy
A.O. Universitaria Policlinico "Riuniti"
Foggia, Apulia, 71100, Italy
Ospedale Santa Maria di Loreto
Napoli, Campania, 80100, Italy
Ospedale Maggiore
Bologna, Emilia Romagan, 40131, Italy
AUSL della Romagna, Ospedale Bufalini
Cesena, Emilia-Romagna, 47023, Italy
Ospedale San Camillo Forlanini
Rome, Lazio, 00152, Italy
Presidio Ospedliero di Cremon
Cremona, Lombardy, 26100, Italy
Niguarda Cà Granda
Milan, Lombardy, 20162, Italy
Ospedale A. Manzoni
Lecco, Lombradia, 23900, Italy
SS. Antonio e Biagio e C. Arrigo
Alessandria, Piedmont, 15100, Italy
Ospedale Edoardo Agnelli
Pinerolo, Piedmont, 10064, Italy
CTO Maria Adelaide
Turin, Piedmont, 10126, Italy
Ospedale Giovanni Paolo II
Olbia, Sardinia, 07026, Italy
AO Villa Sofia - Cervello
Palermo, Sicily, 90100, Italy
Ospedale San Salvatore
Pesaro, The Marches, 61100, Italy
Ospedale del Mugello
Borgo San Lorenzo, Tuscany, 50032, Italy
AO Universitaria Careggi
Florence, Tuscany, 50134, Italy
Ospedale di S. Chiara
Pisa, Tuscany, 56100, Italy
Ospedale di Santa Chiara
Pisa, Tuscany, 56100, Italy
Ospedale Santa Maria della Misericordia
Perugia, Umbria, 06100, Italy
Related Links
Biospecimen
Blood samples day 1 and 5 from ICU admission.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guido Bertolini, MD
Istituto Di Ricerche Farmacologiche Mario Negri
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2013
First Posted
December 6, 2013
Study Start
October 1, 2013
Primary Completion
December 1, 2015
Study Completion
March 1, 2019
Last Updated
March 31, 2022
Record last verified: 2022-03