Baggiani, Marta
Graziano, Francesca
Rebora, Paola
Robba, Chiara
Guglielmi, Angelo
Galimberti, Stefania
Giussani, Carlo
Suarez, Jose I.
Helbok, Raimund
Citerio, Giuseppe http://orcid.org/0000-0002-5374-3161
Funding for this research was provided by:
European Society of Intensive Care Medicine (Synapse-ICU)
Article History
Received: 25 June 2022
Accepted: 10 November 2022
First Online: 5 December 2022
Source of support
: GC reports grants and 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.
: The inclusion criteria were patients enrolled in the SYNAPSE-ICU study (ClinicalTrial.gov NCT03257904) (i.e., aged 18 years or older, diagnosed with traumatic brain injury or acute brain injury and an altered level of consciousness) with a diagnosis of aneurysmal subarachnoid hemorrhage. Approval at the sponsor site by the Ethics Committee, Brianza Azienda Socio Sanitaria Territoriale Monza, was obtained on November 21, 2017, according to the Helsinki Declaration and the International Conference on Harmonization for Good Clinical Practice. The enrolled patients were comatose and could not provide informed consent at recruitment. For this reason, centers referred to their local/national law regarding patients’ lack of capacity and participation in an observational study. Once patients regained capacity, they were required to provide informed consent on using personal data or refuse participation. No further ethical approval was needed for this subanalysis.