CytoSorbents Corporation, a critical care immunotherapy leader commercializing its CytoSorb®blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, announced that the Data Safety Monitoring Board (DSMB) of the German government-funded REMOVE Endocarditis trial recommended continuation of the study following an interim analysis on the first 50 patients of the study.
Prof. Dr. med. Frank Brunkhorst, Director of the Center for Clinical Studies at Jena University Hospital who is providing management and oversight to the REMOVE trial, and Prof. Dr. med. Torsten Doenst, Director of the Clinic for Cardiac and Thoracic Surgery at the University of Jena, provided a joint statement, “The Scientific Advisory Board (SAB) of the Center of Sepsis Control and Care (CSCC) and the Data Safety Monitoring Board (DSMB) of the REMOVE study recommended continuation of the study, based upon results of a pre-specified interim analysis that analyzed cytokine and vasoactive mediator levels as an indicator of the mechanistic mode of action of the device in 28 CytoSorb-treated patients and 22 control patients. There were no device-associated adverse events in the CytoSorb group.”[Read more…] about CytoSorbents Announces the Data Safety Monitoring Board Recommends Continuation of REMOVE Endocarditis Trial