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Cytokine Release SyndromePhase 2JAFRONCPBNCT05349669

Jafron Haemoadsorption During Cardiopulmonary Bypass

A Phase 2 study testing Jafron use during CPB in people with Cytokine Release Syndrome, run by Anthea Hospital Bari at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 10 to 100 years
Conditions the study is for
Cytokine Release Syndrome
What is being tested?
Jafron use during CPB
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteItaly
Study dates
30 May 2022to 15 Sep 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 100 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Anthea Hospital

    Bari, Apulian, 70124

Other trials in Italy

About this study

Official title: 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.

Read the 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.

Being tested
Jafron use during CPB
Medical subject headings
Cytokine Release Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Jafron use during CPBDrug

    Use of filter Jafron during CPB

Study groups in NCT05349669
Study groupRoleWhat they receive
Conventional CPBNo interventionElective cardiopulmonary bypass (CPB) procedures with an expected time >120 minutes for each extracorporeal procedure.
CPB with JafronExperimentalElective cardiopulmonary bypass (CPB) procedures with Jafron use with an expected time >120 minutes for each extracorporealprocedure.
Receives: Drug: Jafron use during CPB

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. cytokines levels

    IL-2, IL-6,TNF-α, IFN gamma

    Measured: 1 hour before start of the cardiopulmonary bypass

  2. cytokines levels

    IL-2, IL-6,TNF-α, IFN gamma,

    Measured: 10 minutes after stop the cardiopulmonary bypass

  3. Hemodynamics supports

    vasoconstrictors use or not use

    Measured: 10 minutes after stop of the cardiopulmonary bypass

  4. Post-operative ITEMS in intensive care unit

    mechanical ventilation (MV) (hours) time and length of stay in intensive care unit (ICU) (hours)

    Measured: 3 days after surgery

Secondary outcomes (3)

  1. Markers levels

    Concentration of Fibrinogen, Albumin, Platelets, Hemoglobin, Hematocrit, White Blood Cells, Neutrophils,Aptoglobin, Cell free Hemoglobin Lymphocytes, Monocytes, Eosinophils, Basophils

    Measured: 1 day before start of the cardiopulmonary bypass

  2. Markers

    Concentration of Fibrinogen, Albumin, Platelets, Hemoglobin, Hematocrit, White Blood Cells, Neutrophils,Aptoglobin, Cell free Hemoglobin Lymphocytes, Monocytes, Eosinophils, Basophils

    Measured: 1 day after stop the cardiopulmonary bypass

  3. Hemodynamics supports

    Need of vasoconstrictors

    Measured: 1 hour after stop the cardiopulmonary bypass

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2022
  2. Study start30 May 2022
  3. Primary completion15 Sep 2022
  4. Study completion15 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05349669
Sponsor's protocol ID
ANTHEAHOSPITAL12022022
Acronym
JAFRONCPB
Status last verified
Feb 2023
First submitted
8 Apr 2022
Last updated
24 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38748856

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Jafron use during CPB in people with Cytokine Release Syndrome, run by Anthea Hospital Bari at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

cytokines levels (time frame: 1 hour before start of the cardiopulmonary bypass). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05349669, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2023.

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