Safety board OKs continuation of CytoSorbents endocarditis trial

CytoSorbents (OTC:CTSO) said this week it the Data Safety Monitoring Board of its REMOVE trial gave the company the green light to continue the study after analyzing data from the first 50 patients. 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 Cardi...
Source: Mass Device - Category: Medical Devices Authors: Tags: Blood Management Clinical Trials Regulatory/Compliance CytoSorbents Corp. Source Type: news