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 | Published | 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 |