CytoSorbents has conducted two multicenter studies with a total of 150 patients for the indications of severe sepsis and septic shock in Europe in order to evaluate the safety and effectiveness of CytoSorb when used continuously up to 24 hours per daily treatment. The company works closely with renowned medical doctors in the field of sepsis research and intensive care. Publication of these studies are planned this year.
In the US, the FDA has approved an IDE application to conduct an initial trial evaluating the intra-operative use of CytoSorb during complex cardiac surgery in several centers. This trial began in Spring 2015 and is due to be completed in the second half of 2016.
In addition to company-sponsored studies, we are pleased to have more than 50 investigator-initiated studies in process with approximately 20 trials actively recruiting, 4 having been completed, and the rest in various stages of planning. A number of these are multicenter projects in either the clinical phase or in preparation, such as in the areas of severe pancreatitis and septic shock.
Overview of the current multicenter studies:
CytoSorbents study ID |
Category |
Country |
Site |
Patient No. |
Status |
Registration |
S20.122-1 |
Septic Shock / ARDS |
Germany |
10 centers, lead: Klinikum Berlin Friedrichshain |
100 |
publication phase |
|
S20.122-2 |
Septic Shock |
Germany |
8 centers, lead: Göttingen University |
50 |
publication phase |
– |
S30.112-1 |
Pancreatitis |
Germany |
Munich Technical university, Weiden hospital |
30 |
recruiting |
|
S10.222-1 |
Cardiopulmonary bypass intraoperative |
USA |
8 sites |
56 |
recruiting |