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Article History

Received: 12 April 2022

Accepted: 11 October 2022

First Online: 22 November 2022

Declarations

:

: Prior to initiation of the trial, permissions were obtained from the Regional Ethics Committee (ID: H-20022320) and the Danish Medicines Agency (ID: 2020033425), and a legal data handling agreement was approved by the Capital Region of Denmark (ID: P-2020–866). Further, a monitoring agreement of adherence to national and international guidelines was made with the GCP-unit of Copenhagen prior to initiation.This trial sought to inhibit the inflammatory state developing in OHCA patients following resuscitation, and injection of study medicine is therefore initiated as soon as possible in the pre-hospital setting. Similar studies and knowledge cannot be obtained in another setting, i.e., in non-comatose patients, and the risks associated to the intervention are considered acceptable. Based on the acute nature of the trial, informed consent of inclusion will be obtained from the primary trial guardian (on-duty physician at the coordinating center of the EMS Copenhagen) which later will be confirmed by the secondary trial guardian (physician at the Department of Thoracic Anesthesiology, Rigshospitalet). Informed consent from the nearest relatives will be obtained as soon as possible following admission to the hospital and further from the patient upon regained consciousness. The process of obtaining consent will be according to national legislation.

: Consent forms for the trial guardians, patient relatives and the patient are all available upon request. All consent forms have been approved by relevant authorities and are written in Danish.

: The authors declare that they have no competing interests.