Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-26 @ 12:50 AM
Study NCT ID:
NCT05542134
Status:
UNKNOWN
Last Update Posted:
2023-05-12
First Post:
2022-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Platelet Agregation in Patients on ECMO
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-11', 'studyFirstSubmitDate': '2022-09-01', 'studyFirstSubmitQcDate': '2022-09-13', 'lastUpdatePostDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Verify now P2Y12 platelet inhibition', 'timeFrame': '(Time Frame: Hour 2 after VA ECMO insertion)', 'description': 'Platelet inhibition measured by VerifyNow as P2Y12 reaction units (PRU). Platelet reactivity reflects P2Y12 inhibitor effect with higher PRU values showing low P2Y12 response and lower values decreased platelet reactivity due to the effect of a P2Y12 inhibitor.'}, {'measure': 'Verify now P2Y12 platelet inhibition', 'timeFrame': '(Time Frame: Hour 4 after VA ECMO insertion)', 'description': 'Platelet inhibition measured by VerifyNow as P2Y12 reaction units (PRU). Platelet reactivity reflects P2Y12 inhibitor effect with higher PRU values showing low P2Y12 response and lower values decreased platelet reactivity due to the effect of a P2Y12 inhibitor.'}, {'measure': 'Verify now P2Y12 platelet inhibition', 'timeFrame': '(Time Frame: Hour 12 after VA ECMO insertion)', 'description': 'Platelet inhibition measured by VerifyNow as P2Y12 reaction units (PRU). Platelet reactivity reflects P2Y12 inhibitor effect with higher PRU values showing low P2Y12 response and lower values decreased platelet reactivity due to the effect of a P2Y12 inhibitor.'}, {'measure': 'Verify now P2Y12 platelet inhibition', 'timeFrame': '(Time Frame: Hour 22 after VA ECMO insertion)', 'description': 'Platelet inhibition measured by VerifyNow as P2Y12 reaction units (PRU). Platelet reactivity reflects P2Y12 inhibitor effect with higher PRU values showing low P2Y12 response and lower values decreased platelet reactivity due to the effect of a P2Y12 inhibitor.'}, {'measure': 'Verify now P2Y12 platelet inhibition', 'timeFrame': '(Time Frame: Hour 48 after VA ECMO insertion)', 'description': 'Platelet inhibition measured by VerifyNow as P2Y12 reaction units (PRU). Platelet reactivity reflects P2Y12 inhibitor effect with higher PRU values showing low P2Y12 response and lower values decreased platelet reactivity due to the effect of a P2Y12 inhibitor.'}, {'measure': 'Verify now P2Y12 platelet inhibition', 'timeFrame': '(Time Frame: Hour 72 after VA ECMO insertion)', 'description': 'Platelet inhibition measured by VerifyNow as P2Y12 reaction units (PRU). Platelet reactivity reflects P2Y12 inhibitor effect with higher PRU values showing low P2Y12 response and lower values decreased platelet reactivity due to the effect of a P2Y12 inhibitor.'}, {'measure': 'Verify now P2Y12 platelet inhibition', 'timeFrame': '(Time Frame: Hour 24 after VA ECMO removal)', 'description': 'Platelet inhibition measured by VerifyNow as P2Y12 reaction units (PRU). Platelet reactivity reflects P2Y12 inhibitor effect with higher PRU values showing low P2Y12 response and lower values decreased platelet reactivity due to the effect of a P2Y12 inhibitor.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['V-A ECMO', 'platelet reactivity', 'ECMO'], 'conditions': ['Platelet Refractoriness']}, 'descriptionModule': {'briefSummary': 'An observational study in which investigators will observe platelet inhibition in patients on VA ECMO acorrding to treatment with P2Y12 inhibitor.', 'detailedDescription': 'Investigators will perform an observational study in which platelet inhibition in patients on VA ECMO acorrding to treatment with P2Y12 inhibitor will be observed.\n\nParticipants will be divided into three groups:\n\nA: patients on V-A ECMO without P2Y12 inhibitors B patients on V-A ECMO with P2Y12 inhibitors with administration of P2Y12 inhibitor at the time of ECMO insertion C: patients on V-A ECMO already recieving P2Y12 inhibitors at the time of ECMO insertion.\n\nBlood samples will be taken prior to and at 2, 4, 12, 22, 48, 72 after ECMO insertion and after removal of an ECMO. VerifyNow System will be used to measure platelet agregation (PRU test).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patents treated with ECMO.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients on VA ECMO\n\nExclusion Criteria:\n\n* known P2Y12 alergy\n* thrombocitopenic patents (\\< 50\\*109/L),\n* patients treated with eptifibatide ali bivalirudin\n* patients younger than 18 years\n* pregnant patients'}, 'identificationModule': {'nctId': 'NCT05542134', 'briefTitle': 'Platelet Agregation in Patients on ECMO', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Centre Ljubljana'}, 'officialTitle': 'Platelet Agregation in Patients on ECMO', 'orgStudyIdInfo': {'id': 'KOIIM-UM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'V-A ECMO without P2Y12 inhibitors', 'description': 'control group', 'interventionNames': ['Diagnostic Test: P2Y12 Platelet Aggregation Inhibitor']}, {'label': 'V-A ECMO with P2Y12 inhibitor at the time of ECMO', 'description': 'observational group 1', 'interventionNames': ['Diagnostic Test: P2Y12 Platelet Aggregation Inhibitor']}, {'label': 'V-A ECMO already recieving P2Y12 inhibitors', 'description': 'observational group 2', 'interventionNames': ['Diagnostic Test: P2Y12 Platelet Aggregation Inhibitor']}], 'interventions': [{'name': 'P2Y12 Platelet Aggregation Inhibitor', 'type': 'DIAGNOSTIC_TEST', 'description': 'Verify now PRU test', 'armGroupLabels': ['V-A ECMO already recieving P2Y12 inhibitors', 'V-A ECMO with P2Y12 inhibitor at the time of ECMO', 'V-A ECMO without P2Y12 inhibitors']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'status': 'RECRUITING', 'country': 'Slovenia', 'contacts': [{'name': 'Marko Noc, MD, phD', 'role': 'CONTACT', 'email': 'marko.noc@kclj.si', 'phone': '+38641723807'}, {'name': 'Ursa Mikuz, MD', 'role': 'CONTACT', 'email': 'ursa.mikuz@gmail.com'}], 'facility': 'UMC Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'centralContacts': [{'name': 'Marko Noc, MD, phD', 'role': 'CONTACT', 'email': 'marko.noc@kclj.si', 'phone': '+38641723807'}, {'name': 'Ursa Mikuz, MD', 'role': 'CONTACT', 'email': 'ursa.mikuz@gmail.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'If needed we are happy to share data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Centre Ljubljana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Marko Noc', 'investigatorAffiliation': 'University Medical Centre Ljubljana'}}}}