Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT04393805
Status:
COMPLETED
Last Update Posted:
2021-03-18
First Post:
2020-05-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Heparins for Thromboprophylaxis in COVID-19 Patients: HETHICO Study in Veneto
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D019851', 'term': 'Thrombophilia'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}], 'ancestors': [{'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 744}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-17', 'studyFirstSubmitDate': '2020-05-16', 'studyFirstSubmitQcDate': '2020-05-16', 'lastUpdatePostDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bleeding', 'timeFrame': '28 days', 'description': 'Collect and evaluate in real-life the safety data of the anti-coagulant treatments used by estimating the incidence of bleeding complications during hospitalization.'}, {'measure': 'Thrombosis', 'timeFrame': '28 days', 'description': 'Collect and evaluate in real-life the efficacy data of the anti-coagulant treatments used by estimating the incidence of deep vein thrombosis and/or pulmonary embolism during hospitalization.'}, {'measure': 'Mortality', 'timeFrame': '28 days', 'description': 'Collect and evaluate in real-life the data by estimating incidence of intra-hospital death.'}], 'secondaryOutcomes': [{'measure': 'Worsening', 'timeFrame': '28 days', 'description': 'clinical worsening with transfer to the intensive/sub-intensive ward'}, {'measure': 'LOS', 'timeFrame': '60 days', 'description': 'length of stay'}]}, 'oversightModule': {'isFdaRegulatedDrug': True}, 'conditionsModule': {'keywords': ['COVID-19 pandemic', 'Hypercoagulability state', 'Thromboprophylaxis', 'Heparin'], 'conditions': ['COVID-19', 'Hypercoagulability']}, 'referencesModule': {'references': [{'pmid': '35244208', 'type': 'DERIVED', 'citation': 'Flumignan RL, Civile VT, Tinoco JDS, Pascoal PI, Areias LL, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.'}, {'pmid': '33502773', 'type': 'DERIVED', 'citation': 'Flumignan RL, Tinoco JDS, Pascoal PI, Areias LL, Cossi MS, Fernandes MI, Costa IK, Souza L, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Prophylactic anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD013739. doi: 10.1002/14651858.CD013739.'}]}, 'descriptionModule': {'briefSummary': 'The HETHICO study aims to collect retrospectively documented clinical information on patients hospitalized in Veneto Region (Italy) for SARS-COVID-2 infection in 2 types of settings, medical environment (COORTE MED), and intensive / sub-intensive (COORTE ICU), to assess the safety and possible efficacy of the anticoagulant treatments used for thromboprophylaxis, or in preventing thrombotic complications related to hospitalization from COVID-19.', 'detailedDescription': 'The HETHICO study aims to collect retrospectively documented clinical information on patients hospitalized in Veneto Region (Italy) for SARS-COVID-2 infection in 2 types of settings, medical environment (COORTE MED), and intensive / sub-intensive (COORTE ICU), to assess the safety and possible efficacy of the anticoagulant treatments used for thromboprophylaxis, or in preventing thrombotic complications related to hospitalization from COVID-19.\n\nFurthermore, the possible association between the observed clinical evolution and the type of antithrombotic prophylaxis performed (class of drug and dose intensity) will be assessed in a large cohort of patients hospitalized in the various participating hospitals in the Veneto region and observed with follow-up. in the short term, gathering information on:\n\nClinical outcomes, Survival, Concomitant pathologies, Adverse events of anticoagulant drugs, Interactions with other concomitant drugs, and Risk factors.\n\nThe collected data, suitably anonymized, will be used to produce scientific works, the standardization of care paths, and the planning of targeted training events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All subjects of both sexes, aged 18 years or older (no maximum age of inclusion) will be eligible for this study, who have been hospitalized in the participating Operating Units (Centers) of Veneto Region Hospitals with infection SARS-COVID-2.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* proved SARS-COVID-2 infection\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT04393805', 'acronym': 'HETHICO', 'briefTitle': 'Heparins for Thromboprophylaxis in COVID-19 Patients: HETHICO Study in Veneto', 'organization': {'class': 'OTHER', 'fullName': 'Quovadis Associazione'}, 'officialTitle': 'Heparins for Thromboprophylaxis in COVID-19 Patients: HETHICO Study in Veneto', 'orgStudyIdInfo': {'id': 'HETHICO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MED-Cohort', 'description': 'Patients hospitalized for SARS-COVID-2 infection in a medical ward', 'interventionNames': ['Drug: Low Molecular Weight Heparin']}, {'label': 'ICU-Cohort', 'description': 'Patients hospitalized for SARS-COVID-2 infection in a sub-intensive or intensive care unit', 'interventionNames': ['Drug: Low Molecular Weight Heparin']}], 'interventions': [{'name': 'Low Molecular Weight Heparin', 'type': 'DRUG', 'otherNames': ['LMWH'], 'description': 'Thromboprophylaxis with Low Molecular Weight Heparin, mostly enoxaparin', 'armGroupLabels': ['ICU-Cohort', 'MED-Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35138', 'city': 'Padua', 'country': 'Italy', 'facility': 'Giuseppe Camporese', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}], 'overallOfficials': [{'name': 'Paolo Simioni, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Medicine, University of Padua (I)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Quovadis Associazione', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Padova', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}