Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2026-01-03 @ 3:33 AM
Study NCT ID:
NCT03090893
Status:
WITHDRAWN
Last Update Posted:
2018-09-10
First Post:
2017-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Response of Continuous Recombinant Antithrombin Infusion in Postcardiotomy ECMO Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C537779', 'term': 'Antithrombin deficiency type 2'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'PI passed away', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-06', 'studyFirstSubmitDate': '2017-03-21', 'studyFirstSubmitQcDate': '2017-03-21', 'lastUpdatePostDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of time within the serum AT level target range of 80-100%', 'timeFrame': '72 hour infusion period', 'description': 'Target value of Antithrombin is recorded as %'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Antithrombin Deficiency Type 2']}, 'descriptionModule': {'briefSummary': 'The objective of this study will be to prospectively evaluate the response of a continuous infusion of recombinant human antithrombin concentrate (rhAT) (ATRYN®) to achieve and maintain the AT activity within a specified range in adult patients that require extracorporeal membrane oxygenation (ECMO) following cardiopulmonary bypass (CPB) and cardiac surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Completed cardiac surgery with Cardiopulmonary Bypass and subsequently placed on venoarterial (VA) Extracorporeal Membrane Oxygenation (ECMO) support at any point during the ongoing hospitalization\n* Serum Antithrombin \\< 60%.\n\nExclusion Criteria:\n\n* Heart transplantation during ongoing hospitalization\n* Excessive bleeding (300 ml/hr of chest tube drainage for 2 consecutive hours)\n* Weight \\< 40 kg\n* Allergy to goat products\n* Anticoagulation with a direct thrombin inhibitor\n* Religious exception to blood products\n* Hypothermia (\\< 34°C)'}, 'identificationModule': {'nctId': 'NCT03090893', 'briefTitle': 'Response of Continuous Recombinant Antithrombin Infusion in Postcardiotomy ECMO Patients', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'A Pilot Study, Prospective, Non-Randomized, Non-Blinded, Single-Center Study Evaluating the Response of Continuous Recombinant Antithrombin (ATryn) Infusion in Postcardiotomy ECMO Patients', 'orgStudyIdInfo': {'id': '15-001713'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Infusion group', 'description': 'Subjects will receive ATryn continuous infusion for maintaining serum antithrombin III levels between 80 - 100', 'interventionNames': ['Drug: ATryn continuous infusion']}], 'interventions': [{'name': 'ATryn continuous infusion', 'type': 'DRUG', 'description': 'replenish serum thrombin levels', 'armGroupLabels': ['Infusion group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'William C. Oliver, Jr., MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'will not share individual patient data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'rEVO Biologics', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'William C. Oliver', 'investigatorAffiliation': 'Mayo Clinic'}}}}