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CytoSorb

Phase 3

Elective Cardiac Surgical Interventions | Unknown | Other |Cytosorbents Corporation|Last Updated: Feb 23, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedNO_TREATMENT_CONTROLLED
Total Trials1
Total Enrollment46
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01879176Cytokine Removal in Cardiopulmonary Bypass PatientsPHASE3 COMPLETED 46Aug 1, 2013May 1, 2015Feb 23, 20171 Austria
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Study Endpoints
Primary Endpoints
IL-6
1. Preoperative 2. Before CBP 3. After CPB 4. 2 hours after CPB 5. 24 hours 6. 48 hours 7. 120 hours
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CytoSorbEXPERIMENTALFor 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 .
ControlNO_INTERVENTIONNo filter will be installed on the CPB machine.
Interventions
NameTypeDescription
CytoSorbDEVICE -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

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...

Countries:Austria
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