van Beekum, Cornelius J. http://orcid.org/0000-0002-3347-2675
von Websky, Martin W.
Willis, Maria A.
Panknin, Christina
Coenen, Martin
Fimmers, Rolf
Kalff, Jörg C.
Wehner, Sven
Vilz, Tim O.
Funding for this research was provided by:
Faculty of Medicine of the University of Bonn (2017-FKS-05)
Universitätsklinikum Bonn
Article History
Accepted: 18 September 2021
First Online: 2 October 2021
Declarations
:
: The study protocol was approved by the federal authority (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) (94.1.04–5660-11826) and the local ethics committee (078/19-MPG) and will be conducted according to the principles of ICH-GCP (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use Guideline for Good Clinical Practice) and the Declaration of Helsinki in the Department of Surgery of the University Hospital of Bonn. All participants are insured by HDI-Gerling, Germany. Any protocol modifications (changes to eligibility criteria, outcomes, etc.) need to be approved by the relevant parties (ethics committee and BfArM) before they are implemented. This study protocol adhered to the SPIRIT guidelines.
: All participants will be informed by an investigator (physician) about the NeuroSIRS-Study and must provide a written informed consent before any study-specific procedure is carried out. Participants can withdraw from the study any time.
: Findings from the study will be disseminated through publications in peer-reviewed journals after obtaining informed consent for publication.
: The authors declare no competing interests.