Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
Study NCT ID:
NCT06254404
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-12
First Post:
2024-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Protamine Dose Reduction on Platelet Aggregation After Extracorporeal Circulation for Minimally Invasive Aortic Valve Replacement Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011479', 'term': 'Protamines'}], 'ancestors': [{'id': 'D009687', 'term': 'Nuclear Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009698', 'term': 'Nucleoproteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-02', 'studyFirstSubmitDate': '2024-02-02', 'studyFirstSubmitQcDate': '2024-02-02', 'lastUpdatePostDateStruct': {'date': '2024-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Minimum effective dose of protamine after extracorporeal circulation. A bottom-up and top-down method will define CP 50.', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Protamine Dose', 'Protamine Adverse Reaction']}, 'descriptionModule': {'briefSummary': 'Determining the minimum effective dose of protamine after extracorporeal circulation for mini-sternotomy aortic valve replacement surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Mini-sternotomy aortic valve replacement surgery\n* Major patients\n\nExclusion Criteria:\n\n* Hypersensitivity to protamine\n* Coagulation Abnormalities\n* Heparin allergy\n* Pregnant women\n* Jehovah's Witnesses"}, 'identificationModule': {'nctId': 'NCT06254404', 'briefTitle': 'Impact of Protamine Dose Reduction on Platelet Aggregation After Extracorporeal Circulation for Minimally Invasive Aortic Valve Replacement Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Liege'}, 'officialTitle': 'Impact of Protamine Dose Reduction on Platelet Aggregation After Extracorporeal Circulation for Minimally Invasive Aortic Valve Replacement Surgery', 'orgStudyIdInfo': {'id': 'LowProt'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Low dose of Protamine', 'interventionNames': ['Drug: Low dose protamine']}, {'type': 'EXPERIMENTAL', 'label': 'Normal dose of protamine', 'interventionNames': ['Drug: Low dose protamine']}], 'interventions': [{'name': 'Low dose protamine', 'type': 'DRUG', 'description': 'Administration of 70% of the normal dose of protamine', 'armGroupLabels': ['Low dose of Protamine', 'Normal dose of protamine']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Benjamin Javillier, MD', 'role': 'CONTACT', 'email': 'javillier.benjamin@hotmail.com', 'phone': '43667180', 'phoneExt': '+32'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Liege', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Benjamin Javillier, MD', 'investigatorAffiliation': 'University of Liege'}}}}