Approval Probability
TA Base Rate
Adjusted LOA
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CytoSorb · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| CytoSorb | EXPERIMENTAL | For the intervention group, the CytoSorb filter will be installed on the CPB machine in a parallel circuit to the body circulation. The flow through the filter will be driven by a roller pump with 200ml.min-1 . |
| Control | NO_INTERVENTION | No filter will be installed on the CPB machine. |
| Name | Type | Description |
|---|---|---|
| CytoSorb | DEVICE | - |
Inclusion Criteria: * elective cardiac surgical intervention with an expected CBP duration \>120 minutes Exclusion Criteria: * Emergency procedures * Heart transplantation * Elective left ventricular assist device (LVAD) implantation * Pulmonary thromendarterectomy * Declined informed consent * S...
CytoSorb is an investigational therapy being studied for use in elective cardiac surgical interventions. It is designed for patients undergoing these procedures, with the goal of removing cytokines during cardiopulmonary bypass. The therapy is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
CytoSorb is being developed by Cytosorbents Corporation, a company traded on the stock exchange under the ticker symbol CTSO. The company is conducting clinical research to evaluate the safety and efficacy of CytoSorb in patients undergoing elective cardiac surgical interventions.
CytoSorb is currently in Phase 3 clinical development. It is an investigational therapy and has not yet received regulatory approval. The Phase 3 trial for CytoSorb has been completed, and the results will inform potential future regulatory submissions.
CytoSorb has been studied in a Phase 3 clinical trial with the identifier NCT01879176, titled 'Cytokine Removal in Cardiopulmonary Bypass Patients.' This completed trial enrolled 46 participants in Austria and evaluated CytoSorb in patients undergoing elective cardiac surgical interventions.
CytoSorb is not FDA approved. It is an investigational therapy currently in Phase 3 clinical development. The completed Phase 3 trial, NCT01879176, evaluated CytoSorb in elective cardiac surgical interventions, but regulatory approval has not been granted.