What is even more interesting is your post regarding the messed up trial. One could argue that everything rises and falls on leadership. The truth seems to be lost every time someone talks about the trial. The Doctors had the proper protocols in place to conduct the trial. The doctors chose to bypass the protocols to ensure their patients received the filter as the mode of treatment. The doctors saw firsthand the results of the filter and chose to make sure their patient survived the illness. This behavior by the trial doctors skewed the randomization of the first 50+/- patients. Was this the fault of Cytosorbents? On the top level of course as a management oversight situation, but it was the protocol doctors that did it to save their patients.
"MONMOUTH JUNCTION, NJ--(September 7, 2011)- CytoSorbents Corporation (OTC.BB: CTSO.OB - News), a critical care-focused company using blood purification to treat life-threatening illnesses, announced additional data from its recently completed European Sepsis Trial using CytoSorb™, a first-in-class extracorporeal cytokine filter approved for use in the European Union. The Germany-based, randomized, controlled, multi-center trial evaluated the use of CytoSorb™ plus standard of care therapy versus standard of care therapy alone in patients with severe sepsis or septic shock in the setting of lung injury. Data from 100 patients were used to evaluate the safety of CytoSorb™ treatment. Due to a patient randomization issue that was subsequently corrected by institution of electronic randomization, the last 43 patients that completed the trial were used to evaluate clinical efficacy. At the time of enrollment, most of these 43 patients (25 control, 18 treated) had septic shock (94% vs. 100% control) and acute respiratory distress syndrome (67% vs. 56% control), while many had renal failure requiring renal replacement therapy (39% vs. 24% control) before entering the trial. The presence of multiple organ failure reflects the severity of illness in these patients and confers a high expected rate of mortality. "
