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Article History

Received: 12 May 2017

Accepted: 27 March 2018

First Online: 27 April 2018

Ethics approval and consent to participate

: Ethics and regulatory approvals of the protocol and related documents were obtained before commencing the trial at each site according to state or national legislation. The list of responsible ethics committees is provided in Additional file . The study protocol has been updated on several occasions, with each amendment receiving further ethics and regulatory approval. Version 9 is current from 11 July 2017.Unconscious patients with severe TBI will not be able to provide informed consent; therefore, this trial uses a deferral of consent procedure. Informed consent will be obtained from each patient’s legal surrogate for data collection as soon as reasonably possible and appropriate after injury. Patients who recover sufficient cognition to understand an explanation of the trial will additionally be asked to consent to continuation in the trial and the use of their data in the trial, if this is required under the ethics committee approval conditions. In France, patients may be enrolled under an ‘Emergency clause’. More details of the trial protocol and participating hospitals are available from the trial registration site [] as well as from the published study protocol [].

: The authors declare that they have no competing interests.

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