Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-30 @ 2:25 AM
Study NCT ID:
NCT04359992
Status:
UNKNOWN
Last Update Posted:
2020-04-24
First Post:
2020-04-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Hemostasis in Case of Severe COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-04-17', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2021-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-21', 'studyFirstSubmitDate': '2020-04-16', 'studyFirstSubmitQcDate': '2020-04-21', 'lastUpdatePostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Platelet activation intensity with the occurrence of clinical thrombotic complications', 'timeFrame': "Change of platelet activity from admission's day in intensive care unit to 2 days and 7 days"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19 Infection']}, 'referencesModule': {'references': [{'pmid': '36376109', 'type': 'DERIVED', 'citation': 'Tacquard C, Mouriaux C, Delabranche X, Bourdon C, Eckly A, Magnenat S, Sattler L, Gachet C, Mertes PM, Hechler B, Mangin PH. Platelet dysfunction and thrombus instability in flow conditions in patients with severe COVID-19. Thromb Res. 2023 Jan;221:137-148. doi: 10.1016/j.thromres.2022.11.004. Epub 2022 Nov 8.'}]}, 'descriptionModule': {'briefSummary': 'The COVID-19 outbreak has led to a significant increase in the number of patients admitted to intensive care for respiratory distress. Early data indicate a particularly high risk of thrombotic risk to viral lung disease, particularly in the most severe patients, with a particularly high incidence of pulmonary embolism. Catheter thrombosis and extra-renal purification filters are also abnormally common. These thrombotic complications could contribute to the mortality observed in this pathology. The introduction of early curative anticoagulation in the most severe patients has just been proposed by the perioperative hemostasis interest group\n\nBiologically, a significant proportion of patients hospitalized in intensive care have a marked biological inflammatory syndrome, associated with signs of activation of clotting (a frank increase in D-dimers). The presence of circulating anticoagulants is common. Interestingly, thrombocytosis, normally observed in such inflammatory syndromes, is absent.\n\nIn this context, it seems legitimate to explore these patients from a hemostasis perspective to identify the factors that cause this thrombotic over-risk, in order to minimize the occurrence of these complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients hospitalized in intensive care for severe COVID-19 infection', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient (\\<18y)\n* With a SARS-CoV-2 infection confirmed by RT-PCR\n* Hospitalized in intensive care\n\nExclusion Criteria:\n\n* Patients under guardianship/curator\n* Anemia at 7 g/dL at inclusion'}, 'identificationModule': {'nctId': 'NCT04359992', 'acronym': 'THROMBOVID', 'briefTitle': 'Study of Hemostasis in Case of Severe COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Study of Hemostasis in Case of Severe COVID-19', 'orgStudyIdInfo': {'id': '7774'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Extra blood sample', 'type': 'OTHER', 'description': '3 extra blood samples at day 0, 2 and 7'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Charles TACQUARD', 'role': 'CONTACT', 'email': 'charlesambroise.tacquard@chru-strasbourg.fr', 'phone': '369551608', 'phoneExt': '+33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}