Jafron Haemoadsorption During Cardiopulmonary Bypass (JAFRONCPB)

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

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.

Study Overview

• Status: Completed
• Conditions: Cytokine Release Syndrome
• Intervention / Treatment: Drug: Jafron use during CPB

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • Apulian
    • Bari, Apulian, Italy, 70124
      • Anthea Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Anthea Hospital Bari

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2022
• Primary Completion (Actual): September 15, 2022
• Study Completion (Actual): September 15, 2022

Study Registration Dates

• First Submitted: April 8, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 27, 2022

Study Record Updates

• Last Update Posted (Actual): February 24, 2023
• Last Update Submitted That Met QC Criteria: February 22, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Cytokine Release Syndrome
• Other Study ID Numbers: ANTHEAHOSPITAL12022022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No