Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT05270902
Status:
RECRUITING
Last Update Posted:
2025-05-09
First Post:
2022-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Haemoadsorption During Heart Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, single-center, single-blinded, randomized, controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-06', 'studyFirstSubmitDate': '2022-02-02', 'studyFirstSubmitQcDate': '2022-02-26', 'lastUpdatePostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in maximal cytokine peak levels (IL-1β, IL-6, IL-33, TNF-α, IL-10)', 'timeFrame': '5 days', 'description': 'Difference in maximal cytokine peak levels in various cytokine levels compared to baseline measured by ELISA'}], 'secondaryOutcomes': [{'measure': 'Difference of immunosuppression (TTV)', 'timeFrame': '30days', 'description': 'Individual immunosuppression measured by Torque-teno-virus load'}, {'measure': 'Difference of immunosuppression (sST2)', 'timeFrame': '30days', 'description': 'Individual immunosuppression measured by sST2 levels'}, {'measure': 'primary graft dysfunction score', 'timeFrame': '7 days', 'description': 'Differences in primary graft dysfunction score between both groups'}, {'measure': '30-day mortality', 'timeFrame': '30 days', 'description': 'Differences in 30-day mortality between both groups'}, {'measure': 'Mechanical Ventilation', 'timeFrame': 'up to 4 weeks', 'description': 'Differences in length of mechanical ventilation'}, {'measure': 'Delirium', 'timeFrame': '5 days', 'description': 'Differences in Confusion assessment method for the ICU between both groups'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart Transplantation', 'Cytosorb'], 'conditions': ['Heart Transplantation']}, 'descriptionModule': {'briefSummary': 'To investigate whether the use of haemoadsorption (HA) on cardiopulmonary bypass during heart transplantation (HTX) has an effect on circulating cytokine levels for the first 120 hours after HTX and induces a decreased inflammatory response, increased anti-inflammatory response or immunosuppressive response. Additionally, the influence of HA on primary graft dysfunction, postoperative cerebral dysfunction, postoperative fluid accumulation, renal dysfunction, duration of mechanical ventilation, length of ICU-stay and 30-day mortality should be investigated'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients undergoing heart transplantation\n\nExclusion Criteria:\n\n* Declined informed consent\n* Age \\< 18 years#\n* Receiving antileukocyte drugs\n* Receiving TNF-α Blockers, immunosuppressive drugs (e.g. tocilizumab)\n* DCD\n* Ex-vivo perfusion'}, 'identificationModule': {'nctId': 'NCT05270902', 'acronym': 'CytoSorbHTX', 'briefTitle': 'Haemoadsorption During Heart Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Effect of Haemoadsorption During Cardiopulmonary Bypass on Patients After Heart Transplantation', 'orgStudyIdInfo': {'id': '1933/2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Adsorber Group', 'description': 'Surgery with CPB will be performed according to institutional standards, depending on indications and surgical preferences.\n\nFor the intervention group (adsorber-group), the CytoSorb adsorber will be installed on the CPB machine in a parallel circuit to the body circulation. The flow through the filter will be driven by a roller pump with 300-400 ml.min-1.', 'interventionNames': ['Device: CytoSorb Adsorber']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'The control group (no-adsorber group) will be treated similarly, but no filter circuit will be installed.'}], 'interventions': [{'name': 'CytoSorb Adsorber', 'type': 'DEVICE', 'description': 'Polymer based adsorber system for the elimination of cytokines', 'armGroupLabels': ['Adsorber Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'state': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Martin H Bernardi, MD', 'role': 'CONTACT', 'email': 'martin.bernardi@meduniwien.ac.at', 'phone': '004314040041090'}, {'name': 'Martin H Bernardi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Divison of Cardiac Thoracic Vascular Anaesthesia and Intensive Care, Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Martin H. Bernardi, MD, PhD', 'role': 'CONTACT', 'email': 'martin.bernardi@meduniwien.ac.at', 'phone': '0043140400', 'phoneExt': '41090'}], 'overallOfficials': [{'name': 'Martin H. Bernardi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'after completion of study, the results will be published in a peer reviewed journal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. Martin Bernardi', 'investigatorAffiliation': 'Medical University of Vienna'}}}}