Jafron Haemoadsorption During Cardiopulmonary Bypass (JAFRONCPB)
Primary Purpose
Cytokine Release Syndrome
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Jafron use during CPB
Sponsored by
About this trial
This is an interventional treatment trial for Cytokine Release Syndrome
Eligibility 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
Sites / Locations
- Anthea Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Conventional CPB
CPB with Jafron
Arm Description
Elective cardiopulmonary bypass (CPB) procedures with an expected time >120 minutes for each extracorporeal procedure.
Elective cardiopulmonary bypass (CPB) procedures with Jafron use with an expected time >120 minutes for each extracorporealprocedure.
Outcomes
Primary Outcome Measures
cytokines levels
IL-2, IL-6,TNF-α, IFN gamma
cytokines levels
IL-2, IL-6,TNF-α, IFN gamma,
Hemodynamics supports
vasoconstrictors use or not use
Post-operative ITEMS in intensive care unit
mechanical ventilation (MV) (hours) time and length of stay in intensive care unit (ICU) (hours)
Secondary Outcome Measures
Markers levels
Concentration of Fibrinogen, Albumin, Platelets, Hemoglobin, Hematocrit, White Blood Cells, Neutrophils,Aptoglobin, Cell free Hemoglobin Lymphocytes, Monocytes, Eosinophils, Basophils
Markers
Concentration of Fibrinogen, Albumin, Platelets, Hemoglobin, Hematocrit, White Blood Cells, Neutrophils,Aptoglobin, Cell free Hemoglobin Lymphocytes, Monocytes, Eosinophils, Basophils
Hemodynamics supports
Need of vasoconstrictors
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05349669
Brief Title
Jafron Haemoadsorption During Cardiopulmonary Bypass
Acronym
JAFRONCPB
Official Title
Cytokine With Jafron Haemoadsorption During Cardiopulmonary Bypass: Protocol for Randomized Controlled Report
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 30, 2022 (Actual)
Primary Completion Date
September 15, 2022 (Actual)
Study Completion Date
September 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Anthea Hospital Bari
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytokine Release Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional CPB
Arm Type
No Intervention
Arm Description
Elective cardiopulmonary bypass (CPB) procedures with an expected time >120 minutes for each extracorporeal procedure.
Arm Title
CPB with Jafron
Arm Type
Experimental
Arm Description
Elective cardiopulmonary bypass (CPB) procedures with Jafron use with an expected time >120 minutes for each extracorporealprocedure.
Intervention Type
Drug
Intervention Name(s)
Jafron use during CPB
Intervention Description
Use of filter Jafron during CPB
Primary Outcome Measure Information:
Title
cytokines levels
Description
IL-2, IL-6,TNF-α, IFN gamma
Time Frame
1 hour before start of the cardiopulmonary bypass
Title
cytokines levels
Description
IL-2, IL-6,TNF-α, IFN gamma,
Time Frame
10 minutes after stop the cardiopulmonary bypass
Title
Hemodynamics supports
Description
vasoconstrictors use or not use
Time Frame
10 minutes after stop of the cardiopulmonary bypass
Title
Post-operative ITEMS in intensive care unit
Description
mechanical ventilation (MV) (hours) time and length of stay in intensive care unit (ICU) (hours)
Time Frame
3 days after surgery
Secondary Outcome Measure Information:
Title
Markers levels
Description
Concentration of Fibrinogen, Albumin, Platelets, Hemoglobin, Hematocrit, White Blood Cells, Neutrophils,Aptoglobin, Cell free Hemoglobin Lymphocytes, Monocytes, Eosinophils, Basophils
Time Frame
1 day before start of the cardiopulmonary bypass
Title
Markers
Description
Concentration of Fibrinogen, Albumin, Platelets, Hemoglobin, Hematocrit, White Blood Cells, Neutrophils,Aptoglobin, Cell free Hemoglobin Lymphocytes, Monocytes, Eosinophils, Basophils
Time Frame
1 day after stop the cardiopulmonary bypass
Title
Hemodynamics supports
Description
Need of vasoconstrictors
Time Frame
1 hour after stop the cardiopulmonary bypass
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Anthea Hospital
City
Bari
State/Province
Apulian
ZIP/Postal Code
70124
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
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Jafron Haemoadsorption During Cardiopulmonary Bypass
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