CytoSorbents has initiated two multicentre trials involving a total of 150 patients in the European area of sepsis in order to evaluate the safety and efficacy of CytoSorb over a prolonged period of use of up to 24 hours per adsorber cartridge. The first of these studies has already been published and the release of the second study is planned for the near future. The company will continue to work closely with reputable physicians in the field of sepsis and intensive care.
In the United States, the FDA approved a first multi-center study on the intraoperative use of the CytoSorb Adsorber during complex cardiac surgery. This study is intended for clinical evaluation and product approval preparation in the US. It started in spring 2015 and was completed in the second half of 2016. The results of this study (REFRESH I) were presented in part in 2017 at the American Association for Thoracic Surgery Congress in Boston and are currently being prepared for publication. The follow-up study RERFRESH II has already begun.
In addition to these studies initiated by the company, we look forward to more than 50 ongoing investigator-initiated studies, of which approximately 20 are already actively recruiting, 7 completed, and the others are at various stages of planning and execution. 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.
Given the number of projects currently close to completion or already completed, we expect a significant increase in published evidence on the effectiveness and clinical outcomes of CytoSorb therapy over the next few months.
As further studies begin with the inclusion phase, they will be listed here.
Overview of the current multicenter studies:
Septic Shock / ARDS
10 centers, lead: Klinikum Berlin Friedrichshain
8 centers, lead: Göttingen University
Munich Technical University, Weiden hospital
Cardiopulmonary bypass intraoperative
Cardiopulmonary bypass intraoperative (REFRESH II)
Cardiopulmonary bypass intraoperative (infective endocarditis / REMOVE)
International registry on the use of CytoSorb adsorber
Currently around 40 centres