Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
Study NCT ID:
NCT06442267
Status:
RECRUITING
Last Update Posted:
2024-10-29
First Post:
2024-05-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparing Anticoagulation Strategies Using UFH, Argatroban and LMWH for ECMO Support
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C031942', 'term': 'argatroban'}, {'id': 'D006493', 'term': 'Heparin'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2027-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-26', 'studyFirstSubmitDate': '2024-05-27', 'studyFirstSubmitQcDate': '2024-06-02', 'lastUpdatePostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of thromboembolic events during ECMO therapy', 'timeFrame': 'through duration of the ECMO run; an average of 14 days', 'description': 'Clinically relevant thromboembolic events (Clinical suspicion; confirmation via imaging)\n\n* Pulmonary embolism, deep vein thrombosis\n* Intracardiac thrombosis\n* Arterial thromboembolism including myocardial and cerebral infarction\n* Deep vein thrombosis (detected during daily routine sonography)\n* Need to exchange ECMO circuit due to acute or incipient clotting'}], 'secondaryOutcomes': [{'measure': 'Bleeding events', 'timeFrame': 'through duration of the ECMO run; an average of 14 days', 'description': 'Incidence of bleeding events classified according to BARC Criteria'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ECMO', 'Anticoagulation', 'Thromboembolic Event', 'Bleeding', 'extracorporeal life support', 'anticoagulant', 'heparin'], 'conditions': ['Respiratory Insufficiency', 'Circulatory Failure', 'Thromboembolism', 'Bleeding']}, 'descriptionModule': {'briefSummary': 'A three-arm randomized controlled non-inferiority pilot study comparing anticoagulation strategies using unfractionated heparin, argatroban and enoxaparin for extracorporeal membrane oxygenation support conducted as an investigator-initiated, prospective, parallel group, open-label, active comparator controlled, single center, phase IV study to evaluate the non-inferiority of enoxaparin or argatroban for anticoagulation during ECMO therapy in comparison to the current standard, unfractionated heparin, as measured by the incidence of thromboembolic events during the duration of ECMO therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* either\n\n * require ECMO support or\n * have been started on ECMO therapy within the last 12 hours\n\nExclusion Criteria:\n\n* Patients exhibiting contraindications to anticoagulation in general or any of the three investigated substances\n* Patients who are pregnant\n* Patients suffering from a clinically relevant pre-existing coagulopathy\n* Patients, for whom screening, randomization and implementation of study protocol cannot be initiated within 12 hours after cannulation\n* Patients receiving ongoing therapeutic systemic anticoagulation prior to ECMO implantation, or exhibiting an indication for therapeutic anticoagulation (e.g., pulmonary embolism)\n* Patients whose total duration of ECMO support lasts less than 24 hours\n* Patients with start of ECMO support during CPR (eCPR)\n* Patients with passive decarboxylation, without an active pumping system\n* Patients, who have been weaned off ECMO support within the last 30 days\n* Patients with central ECMO cannulation and/or after cardiopulmonary bypass'}, 'identificationModule': {'nctId': 'NCT06442267', 'acronym': 'CASUAL-ECMO', 'briefTitle': 'Comparing Anticoagulation Strategies Using UFH, Argatroban and LMWH for ECMO Support', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'A Three-arm Randomized Controlled Non-inferiority Pilot Study Comparing Anticoagulation Strategies Using Unfractionated Heparin, Argatroban and Low-molecular-weight Heparin for Extracorporeal Membrane Oxygenation Support', 'orgStudyIdInfo': {'id': '1644/2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enoxaparin group', 'description': 'Anticoagulation for the duration of the study will be conducted using subcutaneous Enoxaparin', 'interventionNames': ['Drug: Enoxaparin Injectable Solution']}, {'type': 'EXPERIMENTAL', 'label': 'Argatroban group', 'description': 'Anticoagulation for the duration of the study will be conducted using intravenous Argatroban.', 'interventionNames': ['Drug: Argatroban, 1 Mg/mL Intravenous Solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Unfractionated heparin group', 'description': 'Anticoagulation for the duration of the study will be conducted using intravenous unfractionated heparin', 'interventionNames': ['Drug: Unfractionated heparin']}], 'interventions': [{'name': 'Enoxaparin Injectable Solution', 'type': 'DRUG', 'description': 'Subcutaneous Enoxaparin will be dosed at 0.5 mg/kg twice daily', 'armGroupLabels': ['Enoxaparin group']}, {'name': 'Argatroban, 1 Mg/mL Intravenous Solution', 'type': 'DRUG', 'description': 'Intravenous Argatroban will be administered as a continuous infusion of 0.1-1 µg/kg/min with a target modified thrombin time measured using Hemoclot of 0,40 - 0,60 µg/mL.', 'armGroupLabels': ['Argatroban group']}, {'name': 'Unfractionated heparin', 'type': 'DRUG', 'description': 'Unfractionated heparin will be administered as a continuous infusion of 7.5-20 units/kg/h with a target Anti FXa calibrated for UFH of 0.3-0.5 u/mL.', 'armGroupLabels': ['Unfractionated heparin group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'state': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Vincenz Scharner, Dr. med.', 'role': 'CONTACT', 'email': 'vincenz.scharner@meduniwien.ac.at'}], 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Vincenz Scharner, MD', 'role': 'CONTACT', 'email': 'vincenz.scharner@meduniwien.ac.at', 'phone': '+43 1 40400', 'phoneExt': '4100'}], 'overallOfficials': [{'name': 'Johannes Gratz, PD, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical Univeristy of Vienna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Johannes Gratz', 'investigatorAffiliation': 'Medical University of Vienna'}}}}