Cytokine removal during complex heart surgery
Cytokine Adsorption During Complex Cardiac Surgery: the JACCS Controlled Randomized Clinical Trial
NA · Centre Hospitalier Universitaire Vaudois · NCT06512623
This study is testing if a new treatment that removes certain inflammatory substances from the blood during heart surgery can help patients recover better and have fewer complications.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire Vaudois (other) |
| Locations | 1 site (Lausanne, Vaud) |
| Trial ID | NCT06512623 on ClinicalTrials.gov |
What this trial studies
This prospective randomized controlled trial evaluates the safety and efficacy of hemoadsorption using HA-380® during cardiopulmonary bypass in patients undergoing complex cardiac surgery. The study aims to determine if removing inflammatory cytokines from the blood during surgery can reduce postoperative complications associated with inflammation. Patients will be randomly assigned to receive either the hemoadsorption treatment along with standard care or standard care alone. Blood samples will be collected at various stages to measure cytokine levels and monitor patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults scheduled for complex cardiac surgeries that require prolonged cardiopulmonary bypass.
Not a fit: Patients who are undergoing off-pump procedures or have contraindications to hemoadsorption will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative complications and improve recovery for patients undergoing complex cardiac surgeries.
How similar studies have performed: While the approach of cytokine removal during cardiac surgery is innovative, similar studies have shown promise in reducing inflammation and improving outcomes, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adults (≥18 years old at study inclusion) 2. Planned for one of the following cardiac surgical procedures: heart transplantation after L-VAD (left ventricular assist device) implantation, OR surgical repair of a type A aortic dissection, OR urgent (within a few days) or emergent (within 24 hours) procedure for acute infectious endocarditis, OR cardiac surgery likely to require \>180 min CPB time as estimated by the surgical team 3. Signed informed consent Exclusion Criteria: 1. Indication to receive hemoadsorption during CPB for drugs removal 2. Women who are pregnant or breastfeeding (pregnancy test done as standard of care) 3. Previous enrolment into the current study 4. Off-pump procedure 5. Chronic immunosuppression 6. Known allergy to heparin or heparin induced thrombocytopenia 7. Severe thrombopenia (platelets count before surgery \< 20g/L) 8. Patient who does not want to be informed of incidental findings 9. Participation in another study with investigational drug within the 30 days preceding and during the present study 10. Participation in another conflicting research study
Where this trial is running
Lausanne, Vaud
- Centre Hospitalier Universitaire Vaudois — Lausanne, Vaud, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Antoine Schneider — CHUV Centre Hospitalier Universitaire Vaudois (CHUV)
- Study coordinator: Isabelle Cristiani
- Email: isabelle.cristiani@chuv.ch
- Phone: +4179 556 84 60
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: Post-cardiac Surgery, Inflammation, Organ Dysfunction Syndrome, Cardiac Disease, Cardio-Pulmonary Bypass, Post-pump syndrom, Cytokine Hemoadsorption, Post-operative organ failure