Multicenter studies

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

Link

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

Link

S20.112-1

Septic Shock

UK

Lead: University College London

130

in preparation