CytoSorbents has initiated several multicentre trials, which have either already been published, or are ongoing in various stages. Published studies confirm the safety and efficacy of CytoSorb. The company continues to work closely with reputable institutions and physicians in the fields of cardiac surgery, sepsis and intensive care.
In the United States, the FDA approved two multi-center studies on the intraoperative use of the CytoSorb adsorber during complex cardiac surgery. Both studies are intended for clinical evaluation and product approval preparation in the US. The first of these studies (REFRESH I) started in 2015 and was completed in 2016, with results published in 2019. The follow-up study REFRESH II has already begun.
There are many investigator-initiated trials in progress, some of which are already actively recruiting and others already completed and published (see CytoSorb Literature Database for more details). The remaining studies are at different stages of preparation and implementation. Some of these studies are multi-center projects in the clinical phase or in preparation, for example in the areas of severe pancreatitis and septic shock.
Some of these projects are currently nearing completion or have already been completed, therefore we expect to continue to see a significant increase in published evidence on the effectiveness and clinical outcomes of CytoSorb therapy.
Example of some of the current multicenter studies:
Septic shock / ARDS
10 sites, Lead: Klinikum Berlin Friedrichshain
8 sites, Lead: Universität Göttingen
Technical University Munich, Hospital Weiden
Cardiopulmonary bypass intraoperative
Cardiopulmonary bypass intraoperative (REFRESH II)
Cardiopulmonary bypass intraoperative (infective endocarditis / REMOVE)
International Registry CytoSorb Adsorber
ongoing ca. 50 sites
4 sites, Lead: Emden