Jafron Haemoadsorption During Cardiopulmonary Bypass

Phase 2

Completed

• Conditions: Cytokine Release Syndrome
• Interventions: Drug: Jafron use during CPB

• Registration Number: NCT05349669
• Lead Sponsor: Anthea Hospital Bari

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-04-08
• Study First Submitted QC: 2022-04-21
• Study First Posted: 2022-04-27
• Study Start: 2022-05-30
• Primary Completion: 2022-09-15
• Study Completion: 2022-09-15
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-22
• Last Update Posted: 2023-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPB with Jafron	Jafron use during CPB	Elective cardiopulmonary bypass (CPB) procedures with Jafron use with an expected time \>120 minutes for each extracorporealprocedure.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Anthea Hospital; 🇮🇹 Bari, Apulian, Italy