Jafron Haemoadsorption During Cardiopulmonary Bypass

In this context the investigators introduce the study design for multi-centre pilot randomized report in 40 patients undergoing elective CPB procedures with an expected time >120 minutes for each extracorporeal procedure. Patients will be randomly allocated to either standard of care (n = 20) or Jafron HA(n = 20) during cardiopulmonary bypass (CPB). The primary outcome will be the difference between the two groups in cytokines levels (IL-2, IL-6,TNF-α, IFN gamma) and secondary parameters (Fibrinogen, Albumin, Platelets, Hemoglobin, Hematocrit, White Blood Cells, Neutrophils,Lymphocytes, Monocytes, Eosinophils, Basophils) will measured at anaesthesia induction, at the endof CPB , Primary outcomes: hemodynamics with or without vasoconstrictors use, the mechanical ventilation (MV) (hours) time and length of stay in intensive care unit (ICU) (hours). This prospectivemulti-centre randomized controlled report will take place in two Centres: Anthea Hospital, GVMCare & Research, Bari, Italy; Virgen de la Arrixaca University Hospital, Murcia, Spain; between May 2022 and September 2022. The target population per centre will include (n=20) patients; will beallocate for each center to either standard of care (n = 10) or Jafron HA (n = 10) planned for elective cardiac surgery with increased risk of cytokine release.

Inclusion criteria

• elective cardiac surgery under CPB
• double valve replacement or a complex surgery with an expected CPB duration > 120 min
• redo cardiac surgery

Exclusion criteria

• end-stage renal disease (dialysis dependence)
• active infectious endocarditis
• emergency or off-pump procedure
• prescription of non-steroidal antiinflammatory medication (except for low-dose aspirin) or corticosteroids within 7 days
• enrolment in another conflicting study
• administration of human albumin during CPB