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Multicenter Studies

CytoSorbents has initiated several multicentre trials, which have either already been published, or are ongoing in various stages. Published studies confirm the safety and efficacy of CytoSorb. The company continues to work closely with reputable institutions and physicians in the fields of cardiac surgery, sepsis and intensive care.

In the United States, the FDA approved two multi-center studies on the intraoperative use of the CytoSorb adsorber during complex cardiac surgery. Both studies are intended for clinical evaluation and product approval preparation in the US. The first of these studies (REFRESH I) started in 2015 and was completed in 2016, with results published in 2019. The follow-up study REFRESH II has already begun.

There are many investigator-initiated trials in progress, some of which are already actively recruiting and others already completed and published (see literature.cytosorb-therapy.com for more details). The remaining studies are at different stages of preparation and implementation. Some of these studies are multi-center projects in the clinical phase or in preparation, for example in the areas of severe pancreatitis and septic shock.

Some of these projects are currently nearing completion or have already been completed, therefore we expect to continue to see a significant increase in published evidence on the effectiveness and clinical outcomes of CytoSorb therapy.

Example of some of the current multicenter studies:

CytoSorbents
study ID
Category
Country
Site
Patient No
Status
Registration
S20.122-1
Septic shock / ARDS
Germany
10 sites, Lead: Klinikum Berlin Friedrichshain
100
Published
Link
S09
Septic shock
Germany
8 sites, Lead: Universität Göttingen
50
Publication phase
P01
Pancreatitis
Germany
Technical University Munich, Hospital Weiden
30
Recruiting
Link
S10.222-1
Cardiopulmonary bypass intraoperative
USA
8 sites
56
Published
Link
CS118
Cardiopulmonary bypass intraoperative (REFRESH II)
USA
Multiple
400
On hold
Link
CS101
Cardiopulmonary bypass intraoperative (infective endocarditis / REMOVE)
Germany
14 sites
250
Data Analysis
Link
O01
International Registry CytoSorb Adsorber
worldwide
ongoing ca. 50 sites
NA
Recruiting
Link
CytoScore
Septic shock
Germany
4 sites, Lead: Emden
500
Data Analysis
Link
TISORB
Cardiac surgery
UK
8 sites
30
Recruiting
Link