Multicenter studies

CytoSorbents has conducted two multicenter studies in Europe with a total of 150 patients for the indications of sepsis and septic shock, in order to evaluate the safety and effectiveness of CytoSorb when used continuously for up to 24 hours per daily treatment. The first of these studies has been published and the second is planned in the near future. The company continues to work closely with renowned medical doctors in the field of sepsis research and intensive care.

In the USA, the FDA 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 was completed in the second half of 2016. The results of this study (REFRESH I) are currently being prepared for publication having already been presented at the American Association for Thoracic Surgery Congress 2017 in Boston. The successor study to this (REFRESH II) has already started.

In addition to company-sponsored studies, we are pleased to have more than 50 investigator-initiated studies in progress with approximately 20 trials actively recruiting, seven having been completed, and the rest in various stages of planning or execution. 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.
Because of the number of projects that are currently close to completion of the clinical phase, or already completed, we expect an increase in published evidence on the effectiveness and clinical outcomes of CytoSorb therapy in these applications in the coming months.
As more studies begin enrolling, they will be detailed here.

Overview of currently ongoing multicentred 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

Published

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

Link

S10.222-1

Cardiopulmonary bypass intraoperative

USA

8 sites

56

Publication phase

Link

S10.222-2

Cardiopulmonary bypass intraoperative (REFRESH II)

USA

TBD

TBD

Recruiting

./.

S10.112-1

Cardiopulmonary bypass intraoperative (infective endocarditis / REMOVE)

Germany

6 sites

250

Recruiting

Link

S10.222-3

International registry on the use of CytoSorb adsorber

Worldwide

Currently around 30 centres

NA

Recruiting

Link