Clinical trials referenced in this document:
Documents that mention this clinical trial
Comparative effectiveness of surgery in traumatic acute subdural and intracerebral haematoma: study protocol for a prospective observational study within CENTER-TBI and Net-QuRe
Prognostic value of global deep white matter DTI metrics for 1-year outcome prediction in ICU traumatic brain injury patients: an MRI-COMA and CENTER-TBI combined study
High arterial oxygen levels and supplemental oxygen administration in traumatic brain injury: insights from CENTER-TBI and OzENTER-TBI
Clustering identifies endotypes of traumatic brain injury in an intensive care cohort: a CENTER-TBI study
Funding for this research was provided by:
Received: 20 February 2022
Accepted: 2 July 2022
First Online: 27 July 2022
: This sub-study was approved by the CENTER-TBI management committee. The CENTER-TBI study was conducted in accordance with all relevant laws of the European Union if directly applicable or of direct effect and all relevant laws of the country where the Recruiting sites were located, including but not limited to, the relevant privacy and data protection laws and regulations (the “Privacy Law”), the relevant laws and regulations on the use of human materials, and all relevant guidance relating to clinical studies from time to time in force including, but not limited to, the ICH Harmonised Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) (“ICH GCP”) and the World Medical Association Declaration of Helsinki. Informed Consent by the patients or next of kin was obtained, according to the local legislations, for all patients recruited in the Core Dataset of CENTER-TBI and documented in the electronic case report form. Ethical approval for CENTER-TBI was obtained at each recruiting site. The list of sites, Ethical Committees, approval numbers and approval dates are available online [CitationRef removed].
: Not applicable.
: DM reports grants, personal fees and non-financial support from GlaxoSmithKline, grants and personal fees from NeuroTrauma Sciences, personal fees from Pfizer Ltd, personal fees from PressuraNeuro, grants and personal fees from Lantmannen AB, grants and personal fees from Integra, outside the submitted work. All other authors declare no competing interests.