The German gov’t-funded randomized, controlled, multi-center 250-patient REMOVE trial, which was launched in late 2017, looked to explore the safety and efficacy of intraoperative CytoSorb in patients with dangerous bacterial heart valve infections during valve replacement surgeries and cardiopulmonary bypass procedures, the Monmouth, N.J.-based company said.
The study’s goal is to demonstrate improved hemodynamic stability and reduced organ injury, primarily measured by change in the sequential organ failure assessment score, with secondary endpoints of 30-day mortality, need for supportive care therapies and length of intensive care and in-hospital stays.
“The Scientific Advisory Board of the Center of Sepsis Control and Care and the Data Safety Monitoring Board 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,” Dr. Frank Brunkhorst of Jena University Hospital’s Center for Clinical Studies and Dr. Torsten Doenst of Jena University’s Clinic for Cardiac and Thoracic Surgery said in a joint statement.
“We are pleased to have passed this significant milestone for the REMOVE endocarditis trial and thank all of the participating centers for their continued contributions to this important study. We are eager to continue the trial so that we will get important information on the clinical end points in these critically-ill patients. We thank the German government for support. Currently, enrollment is in-line with our goals, and we are confident in being able to advance this trial to completion,” principal investigator Dr. Mahmoud Diab of Jena University’s Clinic for Cardiac and Thoracic Surgery
Last August, Cytosorbents said that it won another round of funding from the U.S. government to commercialize its HemoDefend red blood cell transfusion filter.