Jafron Haemoadsorption During Cardiopulmonary Bypass

NCT05349669 | Completed Phase 2

• 1 other identifier: ANTHEAHOSPITAL12022022
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cytokine Release Syndrome

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Markers levels

  1 day before start of the cardiopulmonary bypass

• Markers

  1 day after stop the cardiopulmonary bypass

• Hemodynamics supports

  1 hour after stop the cardiopulmonary bypass

Study Arms (2)

Conventional CPB

NO INTERVENTION

Elective cardiopulmonary bypass (CPB) procedures with an expected time \>120 minutes for each extracorporeal procedure.

CPB with Jafron

EXPERIMENTAL

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

Drug: Jafron use during CPB

Interventions

Jafron use during CPB DRUG

Use of filter Jafron during CPB

CPB with Jafron

Eligibility Criteria

• Age: 10 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• elective cardiac surgery under CPB
• double valve replacement or a complex surgery with an expected CPB duration \> 120 min
• redo cardiac surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Anthea Hospital Bari: lead

Study Sites (1)

Anthea Hospital

Bari, Apulian, 70124, Italy

Location

Related Publications (1)

• Condello I, Morvillo JB, Fiore F, Teora V, Nasso G, Speziale G. Hemadsorption to Contain Postoperative Cell-Free Hemoglobin and Haptoglobin Preservation for Extended Cardiopulmonary Bypass Time in Cardiac Surgery for Acute Kidney Injuries Prevention. Braz J Cardiovasc Surg. 2024 May 15;39(3):e20230272. doi: 10.21470/1678-9741-2023-0272.

  PMID: 38748856 DERIVED

MeSH Terms

Conditions

Cytokine Release Syndrome

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: April 27, 2022
• Study Start: May 30, 2022
• Primary Completion: September 15, 2022
• Study Completion: September 15, 2022
• Last Updated: February 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)