Using Cytosorb to improve outcomes in heart failure patients receiving LVADs
CYtosorb Modulation of surgiCal infLammatiON During LVAD insErtion
NA · Imperial College London · NCT04596813
This study is testing whether the Cytosorb device can help heart failure patients who are getting a heart pump by reducing inflammation during surgery and improving their recovery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Imperial College London (other) |
| Locations | 1 site (Harefield) |
| Trial ID | NCT04596813 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of the Cytosorb device to reduce inflammatory responses, particularly IL-6, during the implantation of continuous flow left ventricular assist devices (CF-LVAD) in patients with end-stage heart failure. The research aims to assess the efficacy, safety, and feasibility of this treatment, as well as its potential effects on complications such as right ventricular failure and organ dysfunction. Additionally, a biobank will be established to analyze patient biological samples and their inflammatory responses to surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 scheduled for elective LVAD implantation using cardiopulmonary bypass.
Not a fit: Patients who are undergoing LVAD implantation without cardiopulmonary bypass or those with severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative complications and improve survival rates for heart failure patients undergoing LVAD implantation.
How similar studies have performed: Other studies have shown promise in using cytokine hemoadsorption technologies in cardiac surgery, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Adult patients (≥18 years), but ≤70 years; Scheduled for elective LVAD implantation with the use of cardiopulmonary bypass; Written informed consent for participation Exclusion Criteria: * 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 * Application of contrast medium on the day of surgery * Immunosuppressive therapy or long-term therapy with corticosteroids * Contraindication to anticoagulation with heparin * Participation in another clinical intervention trial
Where this trial is running
Harefield
- Harefield Hospital — Harefield, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Eric EC de Waal — UMC Utrecht
- Study coordinator: Nandor Marczin
- Email: n.marczin@imperial.ac.uk
- Phone: +44 1895 823 737
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure, cardiac surgery, inflammation, cytokines, bypass, artificial heart known as LVAD