CytoSorbents Corporation (OTCQB: CTSO), a critical care immunotherapy company using blood purification to treat life-threatening conditions, announced the launch of its International CytoSorb® Treatment Registry, established and managed by the Center of Clinical Trials at the University of Jena, Germany. The registry will collect worldwide CytoSorb® treatment and pharmacovigilance data, voluntarily submitted by treating physicians, from critically-ill patients with diseases such as sepsis, trauma, acute respiratory distress syndrome, pancreatitis, burn injury, liver failure, complications of cardiac surgery, and others. The registry follows Good Clinical Practice (GCP) guidelines and will systematically and securely collect and store de-identified patient data. These data can then be analyzed, evaluated and summarized in future publications under the auspices of an independent scientific advisory board, under Good Practice Secondary Data Analysis (GPS) and Guidelines for Good Epidemiological Practice (GEP) standards, and under quality standards outlined by such agencies as the U.S. Agency for Healthcare Research and Quality (AHRQ), and the German Memorandum Registry for Health Services Research.
Prof. Dr. med. Frank Brunkhorst, Director for the Center of Clinical Trials at the Paul Martini Research Unit of the University of Jena, stated "The International CytoSorb Registry will offer the unique opportunity to assess the effectiveness of CytoSorb® in different clinical settings. As data collection takes place on a broad scale, analyzing this huge amount of real life data will extend knowledge, show potential difficulties and thus lead to an optimized treatment with CytoSorb®. Participating centers contribute their experiences and data to the registry and get periodic analyses of their data in return. It's a win-win situation for both the registry participants and CytoSorbents."
Dr. Robert Bartlett, MD, Chief Medical Officer of CytoSorbents stated, "Capturing up-to-date CytoSorb® treatment and safety data in a registry is an extremely efficient way to see how the device is best being used globally for many different indications. These data will be used for publications and also to guide clinical trial protocols in the future to improve the likelihood of informative and useful studies. It is a pleasure to work with leaders such as Professor Brunkhorst and the team at the University of Jena on this important project."
The English version of the CytoSorb registry is expected to be available later this month.
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