Bouzat, Pierre
Bosson, Jean-Luc
David, Jean-Stéphane
Riou, Bruno
Duranteau, Jacques
Payen, Jean-François
Levrat, Albrice
Abback, Paër-Selim
Duranteau, Jacques
Riou, Bruno
Garrigue, Delphine
Marcotte, Guillaume
David, Jean-Stéphane
Charbit, Jonathan
Asehnoune, Karim
Leone, Marc
Pottecher, Julien
Bouzat, Pierre
,
Funding for this research was provided by:
Ministère de l'Enseignement Supérieur et de la Recherche (PHRCI 2015, n°15-059)
Article History
Received: 2 April 2021
Accepted: 9 August 2021
First Online: 16 September 2021
Declarations
:
: Protocol was approved by the Institutional Review Board Sud-Ouest et Outre Mer II (SOOM II), on <i>June 04, 2017,</i> and authorized by the French competent authority (Agence Nationale pour la Sécurité du Médicament, ANSM) on <i>April 04, 2017</i>. The study is carried out following Good Clinical Practices, the principles of the declaration of Helsinki and European legislation [CitationRef removed]. Because of selection criteria, some enrolled patients are unable to consent (e.g., unconsciousness, agitation, post-traumatic stress). Informed consent can be therefore obtained from patient’s next of kin if present or consent is waived if no one is present at the time of enrolment, as authorized by French law in an emergency situation and approved by the ethics committee. This procedure was already used and authorized in a previous French study on trauma [CitationRef removed]. As soon as the patient’s next of kin is available and capable of informed consent in complete and faithful terms, consent is obtained. Informed consent must also be obtained from the patient whenever he/she becomes able to consent and up to 28 days after trauma. Patients and their next of kin have the right to refuse to participate in the study or revoke their consent at any time. All information appears in an information notice and a consent form given to the subject. All these documents have been approved by the ethics committee. Written informed consent is obtained by the investigator. Two original copies are co-signed by both the investigator and the subject who consent.
: Although it is not anticipated, owing to the trial design, publication of any personal information about a patient will require her/his consent.
: PB, JSD, BR, JD, and JFP received payments from LFB, Les Ullis, France, for lectures and educational content. The other author declares no competing interests.