Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-25 @ 8:40 PM
Study NCT ID:
NCT05349669
Status:
COMPLETED
Last Update Posted:
2023-02-24
First Post:
2022-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Jafron Haemoadsorption During Cardiopulmonary Bypass
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080424', 'term': 'Cytokine Release Syndrome'}], 'ancestors': [{'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-22', 'studyFirstSubmitDate': '2022-04-08', 'studyFirstSubmitQcDate': '2022-04-21', 'lastUpdatePostDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cytokines levels', 'timeFrame': '1 hour before start of the cardiopulmonary bypass', 'description': 'IL-2, IL-6,TNF-α, IFN gamma'}, {'measure': 'cytokines levels', 'timeFrame': '10 minutes after stop the cardiopulmonary bypass', 'description': 'IL-2, IL-6,TNF-α, IFN gamma,'}, {'measure': 'Hemodynamics supports', 'timeFrame': '10 minutes after stop of the cardiopulmonary bypass', 'description': 'vasoconstrictors use or not use'}, {'measure': 'Post-operative ITEMS in intensive care unit', 'timeFrame': '3 days after surgery', 'description': 'mechanical ventilation (MV) (hours) time and length of stay in intensive care unit (ICU) (hours)'}], 'secondaryOutcomes': [{'measure': 'Markers levels', 'timeFrame': '1 day before start of the cardiopulmonary bypass', 'description': 'Concentration of Fibrinogen, Albumin, Platelets, Hemoglobin, Hematocrit, White Blood Cells, Neutrophils,Aptoglobin, Cell free Hemoglobin Lymphocytes, Monocytes, Eosinophils, Basophils'}, {'measure': 'Markers', 'timeFrame': '1 day after stop the cardiopulmonary bypass', 'description': 'Concentration of Fibrinogen, Albumin, Platelets, Hemoglobin, Hematocrit, White Blood Cells, Neutrophils,Aptoglobin, Cell free Hemoglobin Lymphocytes, Monocytes, Eosinophils, Basophils'}, {'measure': 'Hemodynamics supports', 'timeFrame': '1 hour after stop the cardiopulmonary bypass', 'description': 'Need of vasoconstrictors'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cytokine Release Syndrome']}, 'referencesModule': {'references': [{'pmid': '38748856', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria :\n\n* elective cardiac surgery under CPB\n* double valve replacement or a complex surgery with an expected CPB duration \\> 120 min\n* redo cardiac surgery\n\nExclusion criteria:\n\n* end-stage renal disease (dialysis dependence)\n* active infectious endocarditis\n* emergency or off-pump procedure\n* prescription of non-steroidal antiinflammatory medication (except for low-dose aspirin) or corticosteroids within 7 days\n* enrolment in another conflicting study\n* administration of human albumin during CPB'}, 'identificationModule': {'nctId': 'NCT05349669', 'acronym': 'JAFRONCPB', 'briefTitle': 'Jafron Haemoadsorption During Cardiopulmonary Bypass', 'organization': {'class': 'OTHER', 'fullName': 'Anthea Hospital Bari'}, 'officialTitle': 'Cytokine With Jafron Haemoadsorption During Cardiopulmonary Bypass: Protocol for Randomized Controlled Report', 'orgStudyIdInfo': {'id': 'ANTHEAHOSPITAL12022022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Conventional CPB', 'description': 'Elective cardiopulmonary bypass (CPB) procedures with an expected time \\>120 minutes for each extracorporeal procedure.'}, {'type': 'EXPERIMENTAL', 'label': 'CPB with Jafron', 'description': 'Elective cardiopulmonary bypass (CPB) procedures with Jafron use with an expected time \\>120 minutes for each extracorporealprocedure.', 'interventionNames': ['Drug: Jafron use during CPB']}], 'interventions': [{'name': 'Jafron use during CPB', 'type': 'DRUG', 'description': 'Use of filter Jafron during CPB', 'armGroupLabels': ['CPB with Jafron']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70124', 'city': 'Bari', 'state': 'Apulian', 'country': 'Italy', 'facility': 'Anthea Hospital', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anthea Hospital Bari', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ignazio Condello', 'investigatorAffiliation': 'Anthea Hospital Bari'}}}}