JAFRONCPB: Jafron Haemoadsorption During Cardiopulmonary Bypass

• Sponsor: Anthea Hospital Bari (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05349669
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 3.5
• Patients Per Site Per Month: 11.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cytokine Release Syndrome	Drug: Jafron use during CPB	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Cytokine With Jafron Haemoadsorption During Cardiopulmonary Bypass: Protocol for Randomized Controlled Report
• Actual Study Start Date: May 30, 2022
• Anticipated Primary Completion Date: Sep 15, 2022
• Anticipated Study Completion Date: Sep 15, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. cytokines levels [1 hour before start of the cardiopulmonary bypass]

   IL-2, IL-6,TNF-α, IFN gamma

2. cytokines levels [10 minutes after stop the cardiopulmonary bypass]

   IL-2, IL-6,TNF-α, IFN gamma,

3. Hemodynamics supports [10 minutes after stop of the cardiopulmonary bypass]

   vasoconstrictors use or not use

4. 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

1. 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

2. 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

3. Hemodynamics supports [1 hour after stop the cardiopulmonary bypass]

   Need of vasoconstrictors

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anthea Hospital	Bari	Apulian	Italy	70124

Sponsors and Collaborators

• Anthea Hospital Bari

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ignazio Condello, Principal Investigator, Anthea Hospital Bari
• ClinicalTrials.gov Identifier: NCT05349669
• Other Study ID Numbers: ANTHEAHOSPITAL12022022
• First Posted: Apr 27, 2022
• Last Update Posted: Jun 29, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cytokine Release Syndrome

Study Results

No Results Posted as of Jun 29, 2022