RecruitingNot ApplicableNCT04596813

Role of Cytosorb in Left Ventricular Assist Device Implantation

CYtosorb Modulation of surgiCal infLammatiON During LVAD insErtion


Sponsor

Imperial College London

Enrollment

60 participants

Start Date

Sep 21, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

Mechanical circulatory support, specifically implantable continuous flow left ventricular assist device (CF-LVAD) therapy has been established as a viable treatment for rapidly deteriorating patients suffering from end stage heart failure either as bridge or alternative to heart transplantation. However, a large proportion of these patients experience severe complications in the early postoperative period including right ventricular failure or multi organ failure leading to increased mortality. The leading theory explaining these complications involves exaggerated systemic inflammatory response prior to, during and early after CF-LVAD insertion. Among the cytokines IL-6 appears to play a major role. There is increasing demonstration of the efficacy of a cytokine haemoadsorption (HA) technology in attenuating cytokine response and particularly IL-6 in various inflammatory states and emerging data on the safety of the Cytosorb® device in routine and complex cardiac surgery. The study team hypothesizes that Cytosorb® treatment is feasible and safe in heart failure patients undergoing LVAD insertion and that it is effective in attenuating IL-6 secretion with benefit in the wider inflammatory and metabolic response to this high-risk surgery.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether using a blood purification device called CytoSorb during heart surgery to implant a left ventricular assist device (LVAD — a mechanical pump that helps a failing heart move blood) can reduce dangerous inflammation that often occurs when patients are placed on a heart-lung bypass machine. Lowering this inflammation may help patients recover faster and with fewer complications. **You may be eligible if...** - You are between 18 and 70 years old - You are scheduled for planned LVAD implant surgery using a heart-lung bypass machine (not emergency surgery) - You have given written informed consent to participate **You may NOT be eligible if...** - You have advanced HIV (CD4 count below 200 cells per microliter) - You have a very low platelet count (thrombocytopenia) - You received contrast dye on the day of surgery - You are on long-term steroids or immunosuppressive medications - Your surgery is planned without a bypass machine - You are already enrolled in another clinical intervention trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICECytoSorb 300 mL device

Intra-and postoperative CytoSorb hemoadsorption


Locations(1)

Harefield Hospital

Harefield, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04596813


Related Trials