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CREACTIVE C ollaborative RE search on AC ute T raumatic brain I njury (TBI) in intensi V e care medicine in E urope. Country coordinators: Guido Bertolini (IT) - coordinator Akos Csomos (HU) Rafael Kaps (SI) Theodoros Kyprianou (CY) Isaac Lazaar (IL) Malgosia Mikaszewska (PL)
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CREACTIVECollaborative REsearch on ACuteTraumatic brain Injury (TBI) in intensiVe care medicine in Europe Country coordinators: Guido Bertolini (IT) - coordinator AkosCsomos (HU) Rafael Kaps (SI) TheodorosKyprianou (CY) Isaac Lazaar (IL) MalgosiaMikaszewska (PL) NektariaXirouchaki (GR) Funding Agency: European commission
CREACTIVE Start date October 1st, 2013 End date September 30th, 2018 Project duration 60 months Coordinator GiViTI (Italy) Number of partners 9 Number of countries 7 Total budget € 7,032,384 EU contribution € 5,443,350
What are keyaccomplishments in the past 9 months? • Web-based system for project management (center registration, monitoring system, translation manager) • CRF definition and implementation • SOP to collect and storage biological samples • SOP to collect and storage imaging, and software alpha-version • Telephone-based follow-up protocol, and first-stage training course • Authorization of the EC of the participating centers • Start the data collection on 15th March!
Data collection from March 15th to June 24th • 9,000 patients • 8,300 adults • 700 children Projections at the end of the study
What are the major challenges or issues, if any? All the project steps are major challenges … … however, we are particularly worry about: Compliance to the 6-month follow-up Protocol for ambulatory follow-up Feed the centers back with useful analyses on their own performance and the ways to improve Comparison among different countries/regions
What percentage of your data is comprised of the International TBI Common Data Elements and what percentage are unique data elements? All of the Core CDE, but: - Loss of consciousness - Post traumatic amnesia - modified: race category, ethnicity, education, employment About 1/3 of Basic CDE