Multicenter Studies

CytoSorbents has initiated several multicentre trials, which have either already been published, or are ongoing and at 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 critical care.

In the United States, the FDA has approved two multi-center prospective randomized doubled blinded studies on the intraoperative use of the CytoSorb adsorber for antithrombotic removal. The STAR-T (Safe and Timely Antithrombotic Removal – Ticagrelor) and STAR-D (Safe and Timely Antithrombotic Removal – Direct Oral Anticoagulants Apixaban and Rivaroxaban) trials are currently recruiting and aim to be completed late 2022 / early 2023.

There are various investigator-initiated trials in progress, some of which are already actively recruiting and others already completed and published (see CytoSorb Literature Database for more details). The remaining studies are at different stages of preparation and implementation. Some of these studies are multi-center projects, for example in the areas of left ventricular assist device implantation 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 clinical data 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
O06
COSMOS Registry
International
Multiple
3000
Recruiting
Link
P01
Pancreatitis
Germany
Technical University Munich, Hospital Weiden
30
Published
Link
CSI01
Cardiopulmonary bypass intraoperative (infective endocarditis / REMOVE)
Germany
14 sites
250
Published
Link
S18
Septic Shock
Germany
Multiple
160
Recruiting
Link
CT Reg
COVID-19 CTC Registry
USA
Multiple
100
1st 50 pts published. 100 pts in prep.
Link
L02
Liver
Germany
10 sites
30
Recruiting
Link
S14
Septic Shock (MiHaS)
Germany
3 sites
40
Data analysis
Link
CSI08
Cardiopulmonary bypass intraoperative
UK, Netherlands
2 sites
60
Recruiting
Link
STAR
Antithrombotic removal registry
International
Multiple
500
Recruiting
Link
STAR-T
Cardiopulmonary bypass intraoperative
USA
Multiple
120
Recruiting
Link