CREACTIVE Collaborative REsearch on ACute Traumatic brain Injury
CREACTIVE Collaborative REsearch on ACute Traumatic brain Injury (TBI) in intensi. Ve care medicine in Europe COUNTRY COORDINATORS: GUIDO BERTOLINI (IT) - COORDINATOR AKOS CSOMOS (HU) RAFAEL KAPS (SI) THEODOROS KYPRIANOU (CY) ISAAC LAZAAR (IL) MALGOSIA MIKASZEWSKA (PL) NEKTARIA XIROUCHAKI (GR) FUNDING AGENCY: EUROPEAN COMMISSION
CREACTIVE �Start date October 1 st, 2013 �End date September 30 th, 2018 �Project duration 60 months �Coordinator Gi. Vi. TI (Italy) �Number of partners 9 �Number of countries 7 �Total budget € 7, 032, 384 �EU contribution € 5, 443, 350
What are key accomplishments 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 15 th March!
Data collection from March 15 th to June 24 th Expected ICUs Admissions Peds TBI peds %TBI CY 1 2 270 3 20 1 7% GR 10 3 13 0 12 0 92% HU 10 2 230 10 31 6 13% IL 5 1 130 124 13 13 10% IT 80 75 7270 318 547 29 8% PL 15 0 - - - SI 5 4 386 4 52 0 13% 126 87 8299 459 675 49 8% TOT
Data collection from March 15 th to June 24 th Expected ICUs Admissions Peds TBI peds %TBI CY 1 2 270 3 20 1 7% GR 10 3 13 0 12 0 92% HU 10 2 230 10 31 6 13% IL 5 1 130 124 13 13 10% IT 80 75 7270 318 547 29 8% PL 15 0 - - - SI 5 4 386 4 52 0 13% 126 87 8299 459 675 49 8% TOT Projections at the end of the study 9, 000 patients • 8, 300 adults • 700 children
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
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