CYtosorb modulation of surgiCal infLammatiON during LVAD insErtion (CYCLONE-LVAD)
- Conditions
- Heart failure1001928010007593
- Registration Number
- NL-OMON56723
- Lead Sponsor
- Imperial College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 30
Adult patients (>=18 years), but <=70 years;
Scheduled for elective CF-LVAD implantation with the use of cardiopulmonary
bypass;
Written informed consent for participation.
• Poor spoken and/or written language comprehension
• Declined or missing informed consent
• LVAD implant planned without use of CPB
• Total Artificial Heart implantation
• Planned CPB temperature*<*32 °C
• AIDS with a CD4 count of*<*200/µL
• Severe thrombocytopenia (PLT <50000/microliter)
• Application of contrast medium on the day of surgery
• Immunosuppressive therapy or long-term therapy with corticosteroids
• Contraindication to anticoagulation with heparin
- Patients receiving anticonvulsive therapy, including carbamazepine,
lamotrigine, oxcarbazepine, phenytoin, quetiapine and valproat
• Participation in another clinical intervention trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter is the change in plasma IL-6 concentration from the<br /><br>start of surgery, end of cardiopulmonary bypass procedure, at skin closure and<br /><br>at 6, 12, 24, 48 and 72 hours postoperatively.</p><br>
- Secondary Outcome Measures
Name Time Method