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NCT05349669: JAFRONCPB

Jafron Haemoadsorption During Cardiopulmonary Bypass

Completed Phase 2 Last updated 24 February 2023
What this trial tests

Phase 2 trial testing Jafron use during CPB in Cytokine Release Syndrome in 40 participants. Completed in 15 September 2022.

Timeline
30 May 2022
Primary endpoint
15 September 2022
15 September 2022

Quick facts

Lead sponsorAnthea Hospital Bari
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment40
Start date30 May 2022
Primary completion15 September 2022
Estimated completion15 September 2022
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

Anthea Hospital Bari

Who can join

Adults 10 to 100, any sex, with Cytokine Release Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Hemadsorption to Contain Postoperative Cell-Free Hemoglobin and Haptoglobin Preservation for Extended Cardiopulmonary Bypass Time in Cardiac Surgery for Acute Kidney Injuries Prevention.
    Condello I, Morvillo JB, Fiore F, Teora V, et al · · 2024 · cited 4× · PMID 38748856 · DOI 10.21470/1678-9741-2023-0272

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Other recruiting trials for Cytokine Release Syndrome

Currently open trials in the same condition.

Other Anthea Hospital Bari trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05349669.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing