Guglielmi, Angelo
Graziano, Francesca
Bogossian, Elisa GouvĂȘa
Turgeon, Alexis F.
Taccone, Fabio Silvio
Citerio, Giuseppe
,
Funding for this research was provided by:
The European Union FP 7th Framework program (602150)
Funding of additional elements has been provided by the Hannelore Kohl Foundation (Germany) and by the non-profit organization One Mind For Research
Article History
Received: 26 March 2024
Accepted: 3 June 2024
First Online: 14 June 2024
Declarations
:
: The CENTER-TBI study was performed according to the Helsinki Declaration and the International Conference on Harmonization for Good Clinical Practice. Since comatose patients could not provide informed consent during study recruitment, each center referred to local/national law on the lack of capacity. If the patients regained capacity at the follow-up visit, they had to either provide informed consent to use the acute and follow-up data or refuse to participate in the research. Ethical approval for the study was obtained from the Medical Ethics Committees of each participating center, and informed consent was obtained from all participants following local regulations (). For this sub-analysis, no further ethical approval was required.
: Written informed consent for the publication of these data has been previously obtained.
: GC reports grants personal fees as Speakers' Bureau Member and Advisory Board Member from Integra and Neuroptics, all outside the submitted work. The other authors declare no competing interests.