Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-28 @ 6:50 PM
Study NCT ID:
NCT04879550
Status:
COMPLETED
Last Update Posted:
2022-05-24
First Post:
2021-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Investigation of Antithrombin III Deficiency in Adult Patients With ECMO
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020152', 'term': 'Antithrombin III Deficiency'}], 'ancestors': [{'id': 'D025861', 'term': 'Blood Coagulation Disorders, Inherited'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D019851', 'term': 'Thrombophilia'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Antithrombin III activity test'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-22', 'studyFirstSubmitDate': '2021-04-30', 'studyFirstSubmitQcDate': '2021-05-04', 'lastUpdatePostDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antithrombin 3 activity level', 'timeFrame': '5 days', 'description': 'Antithrombin 3 activity test levels will be checked in the first 5 days after ecmo application.'}], 'secondaryOutcomes': [{'measure': 'Thrombosis and Bleeding Events', 'timeFrame': '1 week', 'description': 'Thrombotic or bleeding complications occurring during ECMO run'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Antithrombin III, ECMO'], 'conditions': ['Antithrombin III Deficiency', 'Extracorporeal Membrane Oxygenation Complication']}, 'descriptionModule': {'briefSummary': 'There are publications showing a decrease in Antithrombin III levels of continuous flow and routine heparin therapy in adult patients undergoing Extracorporeal Membrane Oxygenation (ECMO) however, there is not enough data. One of the multifactorial causes affecting bleeding / thrombosis complications and ACT levels may be acquired Antithrombin III deficiency.\n\nThe Antithrombin III activity test results from the patients to be included in the study during the study will be recorded immediately after ECMO run, at the 24th hour before the heparin infusion start and at the 48th, 72nd and 96th hours following the follow-up. The results will be analyzed to figure out a relationship between decreasing Antithrombin 3 values and thrombotic events.', 'detailedDescription': 'ECMO is applied in patients with acute severe heart or lung failure. The treatment protocol of patients undergoing ECMO is carefully arranged against the risk of bleeding / thrombosis.\n\nAccording to the general protocol, heparin infusion therapy is started at the 24th hour after ECMO application. The risk of bleeding / thrombosis is avoided by adjusting the heparin infusion dose with Activated Clotting Time (ACT) control. However, over time, thrombocytopenia and fluctuations in ACT level are observed in patients. It may be necessary to increase the dose of heparin given during the prolonged period. One of the multifactorial causes affecting bleeding / thrombosis complications and ACT levels may be acquired Antithrombin III deficiency. There are publications reporting a decrease in Antithrombin III levels of continuous flow and routine heparin therapy in adult patients undergoing ECMO; however, there is not enough data.\n\nThe Antithrombin III activity test results from the patients to be included in the study during the study will be recorded immediately after ECMO run, at the 24th hour before the heparin infusion start and at the 48th, 72nd and 96th hours following the follow-up. The results will be analyzed to figure out a relationship between decreasing Antithrombin 3 values and thrombotic events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients over the age of 18 who underwent ECMO in our hospital are our study population.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being over the age of 18\n* Patients with ECMO run for 3 days or more (to be able to determine at least 3 antithrombin 3 levels)\n\nExclusion Criteria:\n\n* Patients with ECMO run less than 3 days'}, 'identificationModule': {'nctId': 'NCT04879550', 'briefTitle': 'Prospective Investigation of Antithrombin III Deficiency in Adult Patients With ECMO', 'organization': {'class': 'OTHER', 'fullName': 'Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital'}, 'officialTitle': 'Prospective Investigation of the Association of Antithrombin III Deficiency With Thrombotic Events in Adult Patients With ECMO', 'orgStudyIdInfo': {'id': 'HNEAH-KAEK 2019/81-866'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'thrombotic event developing / not', 'description': 'Group I: Patients with no bleeding/thrombosis complications Group II: Patients with Thrombotic and/or thromboembolic complications Group III: Patients with bleeding complications', 'interventionNames': ['Diagnostic Test: Antithrombin III']}], 'interventions': [{'name': 'Antithrombin III', 'type': 'DIAGNOSTIC_TEST', 'description': 'Antithrombin III deficiency causes thrombosis. Is thrombosis in ECMO patients related to Antithrombin III deficiency? Groups with and without thrombosis will be separated and whether it is related to Antithrombin III deficiency will be evaluated.', 'armGroupLabels': ['thrombotic event developing / not']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34668', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Dr.Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Serap AKA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cardiovascular Surgeon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Arif Yasin Çakmak', 'investigatorAffiliation': 'Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital'}}}}