Haeberle, Helene A.
Calov, Stefanie
Martus, Peter
Serna-Higuita, Lina Maria
Koeppen, Michael
Goll, Almuth
Bernard, Alice
Zarbock, Alexander
Meersch, Melanie
Weiss, Raphael
Mehrländer, Martin
Marx, Gernot
Putensen, Christian
Bakchoul, Tamam
Magunia, Harry
Nieswandt, Bernhard
Mirakaj, Valbona
Rosenberger, Peter
Clinical trials referenced in this document:
Documents that mention this clinical trial
Inhaled prostacyclin therapy in the acute respiratory distress syndrome: a randomized controlled multicenter trial
https://doi.org/10.1186/s12931-023-02346-0
Funding for this research was provided by:
Deutsche Forschungsgemeinschaft (KFO342-1, 374031971, DFG-MI 1506/4-2, 374031971)
Eberhard Karls Universität Tübingen (414-0-0)
Universitätsklinikum Tübingen
Article History
Received: 23 May 2022
Accepted: 26 January 2023
First Online: 18 February 2023
Declarations
:
: The trial was conducted in accordance with Good Clinical Practice guidelines and guiding principles of the Declaration of Helsinki and was approved by the local institutional review boards. The study was approved by the Institutional Review Board of the Research Ethics Committee of the University of Tübingen (899/2018AMG1) and the corresponding ethical review boards of all participating centers. The trial was also approved by the Federal Institute for Drugs and Medical Devices (BfArM, EudraCT No. 2016-003168-37) and registered at clinicaltrials.gov (NCT03111212). Each patient or legal representative was informed about the modalities of the clinical study in accordance with the provided patient information. It was made clear that consent may be withdrawn at any time without giving reasons and without any negative consequences for the patient. Informed consent from the patient was obtained using a form approved by the Ethics committee (EC) of the University of Tübingen or the local EC if the patient was treated in a collaborating institution. The patient or his legal representative and informing physician/investigator each personally signed the informed consent form with an integrated declaration on data privacy protection.
: Not applicable.
: All authors declare that they do not have no conflicts of interest regarding this study.