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Article History

Received: 3 February 2022

Accepted: 14 September 2022

First Online: 30 September 2022

Declarations

:

: This study has been approved by the Institutional Ethics Committee (IEC) of the Chinese Ethics Committee of Registering Clinical Trials. Reference number: ChiECRCT20210137.Investigators have all obtained ethics approval before being allowed to conduct and participate in the study.As injuries are accidental, according to the eligibility criteria, all subjects are incapacitated. Therefore, subjects will not be able to provide informed consent. This study requires the intervention to be carried out rapidly, so it is necessary to enroll eligible patients in the trial as soon as possible after admission. The trial will be conducted in accordance with the Declaration of Helsinki and will follow national legislation on medical research in subjects temporarily incapacitated in emergency situations. In this trial, an investigator who is not involved in the subject’s treatment will be required to obtain guardian consent as early as possible prior to the subject’s inclusion in the study. If a patient’s guardian is present, information about the trial will be provided to them in writing. If the guardian objects, their wishes will be respected. If subjects regain physical and mental capacity to consent, they will be provided with information and wrote informed consent will be sought to proceed with the trial. For any patient who is enrolled but does not regain full capacity, guardian consent will be sought to continue the trial. If the patient or guardian declines consent/consent to continue at this stage, their wishes will be respected. All interactions and attempts to contact the guardian and/or subject will be recorded in the study consent log.

: Not applicable

: The authors declare that they have no competing interests.