Studies and Registries
Access the latest studies, insights, and literature to support your clinical decision-making.
Expertise and clinical evidence
The introduction of new extracorporeal therapies for critically ill patients requires rigorous medical and scientific evaluation to establish their safety profile and clinical performance.
Such a scientific foundation is essential for the appropriate application, professional acceptance, and integration of these therapies into clinical practice, as well as for consideration within healthcare reimbursement frameworks.
CytoSorbents is committed to ongoing clinical research and evidence generation, and to sharing emerging data and practical experience with our clinical partners worldwide to support informed use of our technologies.
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Multicenter Studies
CytoSorbents has initiated and supported multiple multicenter clinical trials in the fields of cardiac surgery, septic shock, and critical care, aimed at further characterizing the clinical performance and safety profile of CytoSorb® Therapy.
Published studies have reported favorable safety data and associations with changes in hemodynamic and inflammatory parameters. In addition, a number of investigator-initiated studies — some still recruiting and others completed — are contributing to the growing body of evidence on CytoSorb use in various critical-care contexts.
Among these are projects investigating the use of CytoSorb Therapy in patients with vasoplegic shock and other fields of use.
The STAR-T double-blind, randomized FDA trial in the United States has been completed with results presented and published. Further peer-reviewed publications are anticipated as ongoing trials reach completion and results become available.CytoSorbents study IDCategoryCountrySitePatient No.StatusRegistrationS18 PROCYSS study Germany 20 260 Ongoing Resource O06 COSMOS Registry International 28 3000 Ongoing Resource P01 Pancreatitis Germany Technical University Munich, Hospital Weiden 30 Published Resource CSI01 Cardiopulmonary bypass intraoperative (infective endocarditis / REMOVE) Germany 14 sites 250 Published Resource CT Reg COVID-19 CTC Registry USA 5 100 Published Resource S14 Septic Shock (MiHaS) Germany 3 sites 40 Data analysis Resource CSI08 Cardiopulmonary bypass intraoperative UK, Netherlands 2 sites 60 Ongoing Resource STAR Antithrombotic removal registry International 30 1000 Ongoing Resource STAR-T Cardiopulmonary bypass intraoperative USA/Canada 29 140 Published Resource CSI01Cardiopulmonary bypass intraoperative (infective endocarditis / REMOVE)Germany14 sites250Published -
Single-center Studies
Multiple clinical centers worldwide are investigating CytoSorbents’ technologies in a range of hyperinflammatory and critical-care conditions.
Research areas include high-risk cardiac surgery involving cardiopulmonary bypass, refractory septic shock, severe burns, and liver failure.
A number of investigator-initiated trials are ongoing or completed, contributing to the growing body of scientific literature on CytoSorb Therapy.
Published studies have reported safety data and associations with changes in inflammatory markers and hemodynamic parameters, while additional publications are expected as more projects reach completion.CytoSorbents study IDCategoryCountrySitePatient No.StatusRegistrationTx04 Orthotopic Heart Transplantation Hungary Semmelweis University, Budapest 60 Published Resource SepsAR3 Septic Shock Germany University Medical Centre, Mainz 150 Recruiting Resource S21 Septic Shock Netherlands Nijmegen Radboud UMC 24 Published Resource S19 Septic Shock Germany Hamburg University Hospital Hamburg-Eppendorf, Hamburg 32 Recruiting Resource O930 VA ECMO (cardiogenic shock) Germany Jena University Hospital 54 Data Analysis Phase Resource O03 Cytokine Release Syndrome Germany Hannover Medical School 34 Recruiting Resource EC05 Post arrest requiring eCPR Germany Freiburg University Hospital, Freiburg 20 Published Resource CYTOCOV-19 COVID-19 patients Germany Hamburg University Hospital Hamburg – Eppendorf, Hamburg 24 Published Resource Cyto-HOPE Liver Transplant Italy Papa Giovanni XXIII Hospital, Bergamo 20 Recruiting Resource CSI26 Cardiac Surgery Netherlands LUMC Leiden 36 Recruiting Resource CSI22 Cardiac Surgery Sweden Sahlgrenska University Hospital Gothenburg 20 Published Resource CSI16 Cardiac Surgery Switzerland Dept of Intensive Care Medicine, Bern 54 Recruiting Resource CSI06 Cardiopulmonary bypass intraoperative Germany Nuremberg hospital 40 Publication phase Resource CGS01 Post cardiac arrest Switzerland Centre Hospitalier Universitaire, Vaudois, Lausanne 40 Published Resource S19Septic ShockGermanyHamburg University Hospital Hamburg-Eppendorf, Hamburg32RecruitingEC05Post arrest requiring eCPRGermanyFreiburg University Hospital, Freiburg20PublishedCYTOCOV-19COVID-19 patientsGermanyHamburg University Hospital Hamburg – Eppendorf, Hamburg24PublishedCSI06Cardiopulmonary bypass intraoperativeGermanyNuremberg hospital40Publication phaseCGS01Post cardiac arrestSwitzerlandCentre Hospitalier Universitaire, Vaudois, Lausanne40Published -
The CytoSorb Registries
The COSMOS (CytoSorb Treatment OF Critically III Patients) registry was opened in mid-2022 and is a company-sponsored international registry designed to provide an infrastructure for the ongoing surveillance of CytoSorb use in real-world critical-care settings, and to serve as an objective, comprehensive, and scientifically-based resource to measure and improve the quality of patient selection for CytoSorb and related treatment modalities. Recruitment is ongoing.
The STAR (Safe and Timely Antithrombotic Removal) registry was first registered with ClinicalTrials.gov in Sept 2021 and is a company sponsored multicenter European Registry designed to capture real-world clinical use patterns and associated clinical outcomes with the use of CytoSorb for the removal of antithrombotic agents. Recruitment is ongoing.
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