Due to the General Data Protection Regulations introduced by the European Union by May 2018, many European clinical trials who started patient recruitment before this time have had to adapt their protocols, informed consent forms and contracts accordingly. This is a huge workload setting up new contracts with all sites and getting approval by the local Ethic Committees and will need many months, especially during these Corona times. Since the legal framework conditions are no longer given, the Centre for Clinical Studies, Jena Germany, has decided to halt patient recruitment in November 2020.
Patient enrolment in the International CytoSorb Registry began in May 2015. This independent, multi-national real-world registry was conducted by the Center for Clinical Studies, University of Jena, Germany, under the leadership of the internationally renowned sepsis researcher Professor Frank Brunkhorst and systematically examined the clinical effects and the safety of CytoSorb therapy under “real-world” routine clinical conditions.
CytoSorbents was thus the first medical technology company to support the market introduction of a new, device-based therapy with a Registry at such a high level by an independent scientific institution. The Registry enabled the systematic review of the clinical effects and the safety of CytoSorb and thus contributed significantly to the expansion of knowledge about CytoSorb therapy.
Data will remain available for ongoing and future analysis and publication projects even after closure of the Registry.