Bentsen, Lasse Paludan
Strøm, Thomas
Forberg, Jakob Lundager
Tiwald, Gerhard
Biesenbach, Peter
Kalmriz, Malik
Rasmussen, Jens Henning
Raaber, Nikolaj
Möller, Sören
Løkke, Mette
Tygesen, Gitte Boier
Nygaard, Hanne
Brok, Josephine Hyldgaard
Andersen, Julie Westergaard
Bajusz, Nikolett
Brabrand, Mikkel
Funding for this research was provided by:
The PhD Fund of The Region of Southern Denmark (22/26271)
The Region of Southern Denmark and Region Zealand’s Research Fund (R38-A1621, R38-A1621, R38-A1621, R42-A2047, R38-A1621, R38-A1621, R38-A1621)
The Medicine Fund of The Danish Regions (1564684, 1564684, 1564684)
Stig & Ragna Gorthons Stiftelse (2024-3057)
University of Southern Denmark
Article History
Received: 30 January 2025
Accepted: 18 March 2025
First Online: 7 April 2025
Declarations
:
: The trial is approved by the Danish Medicines Agency and The Ethical Committee on Medical Research under European Medical Medicines Agency under EU CT ID 2023-504584-16-00. In addition, the trial is registered at clinicaltrials.gov under ID NCT05931601. Patients in the trial are included under the regulation for acute drug trials following the EU regulation no. 536/2014, Chapter V, Article 35 []. Inclusion of trial participants are therefore conducted without prior consent from the patient due to the severity and time-critical condition. The possibility to obtain informed consent is not possible due to the patient’s mental state in the early stages of their condition. After patients are included, the investigators will seek to obtain informed consent in accordance with national law and regulations in the individual participation country.
: The authors declare no competing interests.