CYtosorb Modulation of surgiCal infLammatiON During LVAD insErtion

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Adult patients (≥18 years), but ≤70 years; Scheduled for elective LVAD implantation with the use of cardiopulmonary bypass; Written informed consent for participation

Locations
Other Locations
United Kingdom
Harefield Hospital
RECRUITING
Harefield
Contact Information
Primary
Nandor Marczin
n.marczin@imperial.ac.uk
+44 1895 823 737
Backup
Eric EC de Waal
e.e.c.dewaal@umcutrecht.nl
+88 75 563 76
Time Frame
Start Date: 2020-09-21
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 60
Treatments
No_intervention: standard of care
Active_comparator: standard of care and treatment with the Cytosorb® device
Related Therapeutic Areas
Sponsors
Collaborators: CytoSorbents, Inc, UMC Utrecht
Leads: Imperial College London

This content was sourced from clinicaltrials.gov