Jafron Haemoadsorption During Cardiopulmonary Bypass (JAFRONCPB)

Anthea Hospital Bari

Status and phase

Completed

Phase 2

Conditions

Cytokine Release Syndrome

Treatments

Drug: Jafron use during CPB

Study type

Interventional

Funder types

Other

Identifiers

NCT05349669

ANTHEAHOSPITAL12022022

Details and patient eligibility

About

Cardiopulmonary bypass (CPB) is often associated with degrees of complex inflammatory response mediated by various cytokines. This response can, in severe cases, lead to systemic hypotension and organ dysfunction. Cytokine removal might therefore improve outcomes of patients undergoing cardiac surgery. Jafron is a device designed to remove cytokine from the blood using haemoadsorption (HA). This preliminary report aims to evaluate the potential of Jafron to decrease peri-operative cytokine levels in cardiac surgery.

Full description

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.

Enrollment

40 patients

Sex

All

Ages

10 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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