Jafron Haemoadsorption During Cardiopulmonary Bypass

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Cytokine With Jafron Haemoadsorption During Cardiopulmonary Bypass: Protocol for Randomized Controlled Report

Conditions
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Cytokine Release Syndrome

Intervention / Treatment
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* Drug: Jafron use during CPB


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conventional CPB<br>Elective cardiopulmonary bypass (CPB) procedures with an expected time >120 minutes for each extracorporeal procedure. | |
| Experimental: CPB with Jafron<br>Elective cardiopulmonary bypass (CPB) procedures with Jafron use with an expected time >120 minutes for each extracorporealprocedure. | Drug: Jafron use during CPB<br>* Use of filter Jafron during CPB<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cytokines levels | IL-2, IL-6,TNF-α, IFN gamma | 1 hour before start of the cardiopulmonary bypass | 
| cytokines levels | IL-2, IL-6,TNF-α, IFN gamma, | 10 minutes after stop the cardiopulmonary bypass | 
| Hemodynamics supports | vasoconstrictors use or not use | 10 minutes after stop of the cardiopulmonary bypass | 
| Post-operative ITEMS in intensive care unit | mechanical ventilation (MV) (hours) time and length of stay in intensive care unit (ICU) (hours) | 3 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Markers levels | Concentration of Fibrinogen, Albumin, Platelets, Hemoglobin, Hematocrit, White Blood Cells, Neutrophils,Aptoglobin, Cell free Hemoglobin Lymphocytes, Monocytes, Eosinophils, Basophils | 1 day before start of the cardiopulmonary bypass | 
| Markers | Concentration of Fibrinogen, Albumin, Platelets, Hemoglobin, Hematocrit, White Blood Cells, Neutrophils,Aptoglobin, Cell free Hemoglobin Lymphocytes, Monocytes, Eosinophils, Basophils | 1 day after stop the cardiopulmonary bypass | 
| Hemodynamics supports | Need of vasoconstrictors | 1 hour after stop the cardiopulmonary bypass |