Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2025-12-29 @ 12:15 PM
Study NCT ID:
NCT04388657
Status:
UNKNOWN
Last Update Posted:
2020-05-14
First Post:
2020-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COVID-19, bLOod Coagulation and Thrombosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-13', 'studyFirstSubmitDate': '2020-05-13', 'studyFirstSubmitQcDate': '2020-05-13', 'lastUpdatePostDateStruct': {'date': '2020-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percentage of patients with one or more DVTs.', 'timeFrame': '28 days', 'description': 'The primary outcome measure will be the percentage of patients with one or more DVTs from a lower extremity ultrasound scan.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID', 'Embolism and Thrombosis', 'Pneumonia, Viral']}, 'descriptionModule': {'briefSummary': 'Coronavirus 2 (SARS-CoV2) has been identified as the pathogen responsible for severe acute respiratory syndrome associated with severe inflammatory syndrome and pneumonia (COVID-19).\n\nHaemostasis abnormalities have been shown to be associated with a poor prognosis in these patients with this pneumonia. In a Chinese series of 183 patients, the hemostasis balance including thrombin time, fibrinogenemia, fibrin degradation products and antithrombin III were within normal limits. Only the D-Dimer assay was positive in the whole cohort with an average rate of 0.66 µg / mL (normal \\<50 µg / mL). These hemostasis parameters were abnormal mainly in patients who died during their management; the levels of D-dimers and fibrin degradation products were significantly higher while the antithrombin III was reduced. The findings on the particular elevation of D-dimers in deceased patients as well as the significant increase in thrombin time were also reported in another series. Higher numbers of pulmonary embolisms have been reported in patients with severe form of SARS-COV2 (data in press).\n\nThis research is based on the hypothesis that the existence of deep vein thrombosis (DVT) could make it possible to screen patients at risk of pulmonary embolism and to set up a curative anticoagulation.\n\nThe main objective is to describe the prevalence of deep vein thrombosis in patients hospitalized in intensive care for acute respiratory failure linked to documented SARS-COV2 pneumonia, within 24 hours of their admission.', 'detailedDescription': "Coronavirus 2 (SARS-CoV2) has been identified as the pathogen responsible for severe acute respiratory syndrome associated with severe inflammatory syndrome and pneumonia (COVID-19).\n\nDescribed at the end of 2019 in China, the pandemic sees the number of patients increasing worldwide, Europe being still in the ascending phase of the epidemic and the American continent at the very beginning of it.\n\nHaemostasis abnormalities have been shown to be associated with a poor prognosis in these patients with this pneumonia. In a Chinese series of 183 patients, the hemostasis balance including thrombin time, fibrinogenemia, fibrin degradation products and antithrombin III were within normal limits. Only the D-Dimer assay was positive in the whole cohort with an average rate of 0.66 µg / mL (normal \\<50 µg / mL). These hemostasis parameters were abnormal mainly in patients who died during their management; the levels of D-dimers and fibrin degradation products were significantly higher while the antithrombin III was reduced. The findings on the particular elevation of D-dimers in deceased patients as well as the significant increase in thrombin time were also reported in another series. Higher numbers of pulmonary embolisms have been reported in patients with severe form of SARS-COV2 (data in press).\n\nThis research is based on the hypothesis that the existence of deep vein thrombosis (DVT) could make it possible to screen patients at risk of pulmonary embolism and to set up a curative anticoagulation. This is all the more important since the occurrence of a pulmonary embolism can clearly worsen the right ventricular failure possibly observed during mechanical ventilation in these patients.\n\nCohort study, non-interventional, multicentric, prospective, non-comparative, longitudinal.\n\nThe main objective of the research is to describe the prevalence of deep vein thrombosis in patients hospitalized in intensive care for acute respiratory failure linked to documented SARS-COV2 pneumonia, within 24 hours of their admission.\n\nThe secondary objectives of the research are:\n\n* Identify the factors associated with the existence of deep vein thrombosis\n* Describe the relationship between the inflammatory status of patients on admission and the existence of DVT during follow-up.\n* Describe the relationship between the results of the hemostasis assessment and the existence of deep vein thrombosis during follow-up.\n* Describe the relationship between a right ventricular failure or dysfunction during follow-up and the existence of DVT.\n* Describe the relationship between mortality and the existence of DVT, within 28 days of the patient's admission to intensive care or intensive care. Describe the lung parenchyma if a CT scan is performed"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient admitted in intensive care', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient, male or female, over 18 years of age with no upper age limit.\n* Patient admitted to intensive care or intensive care for pneumonia linked to SARS-COV2 (diagnosed on positive PCR or chest CT and anamnesis)\n* Affiliated patient or beneficiary of a social security scheme\n* Patient having been informed and not objecting to the use of their data in the context of this research.\n\nExclusion Criteria:\n\n* Pregnant, lactating or parturient woman\n* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.'}, 'identificationModule': {'nctId': 'NCT04388657', 'acronym': 'CLOT', 'briefTitle': 'COVID-19, bLOod Coagulation and Thrombosis', 'organization': {'class': 'OTHER', 'fullName': 'Ramsay Générale de Santé'}, 'officialTitle': 'Study of the Prevalence of Deep Vein Thrombosis in Patients Hospitalized in Intensive Care for Acute Respiratory Failure Linked to Pneumonia Documented With SARS-COV2', 'orgStudyIdInfo': {'id': '2020-A00'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Covid Intensive arm', 'description': 'Patients included in intensive care admission by one of the principal investigators from the 3 selectioned centers.', 'interventionNames': ['Diagnostic Test: Echo-Doppler']}], 'interventions': [{'name': 'Echo-Doppler', 'type': 'DIAGNOSTIC_TEST', 'description': 'Utrasound Doppler of the lower limbs', 'armGroupLabels': ['Covid Intensive arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92100', 'city': 'Boulogne-Billancourt', 'state': 'IDF', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Guillaume Peri, Dr', 'role': 'CONTACT', 'email': 'guillaume.geri@aphp.fr'}], 'facility': 'Hôpital Ambroise Paré', 'geoPoint': {'lat': 48.83545, 'lon': 2.24128}}, {'zip': '91300', 'city': 'Massy', 'state': 'IDF', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'DRE Ramsay santé', 'role': 'CONTACT', 'email': 'dre@ramsaygds.fr'}, {'name': 'Wulfran Bougouin', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Privé Jacques Cartier', 'geoPoint': {'lat': 48.72692, 'lon': 2.28301}}, {'zip': '93200', 'city': 'Saint-Denis', 'state': 'IDF', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Julien Nahum, Dr', 'role': 'CONTACT', 'email': 'julien@nahum.fr'}], 'facility': 'Centre Cardiologique du Nord', 'geoPoint': {'lat': 48.93564, 'lon': 2.35387}}], 'centralContacts': [{'name': 'JEAN F OUDET', 'role': 'CONTACT', 'email': 'jf.oudet@ecten.eu', 'phone': '+33683346567', 'phoneExt': '+33683346567'}, {'name': 'MH barba', 'role': 'CONTACT', 'email': 'mh.barba@ecten.eu', 'phone': '+330664888704', 'phoneExt': '+330664888704'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ramsay Générale de Santé', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hôpital Privé Jacques Cartier, service réanimation Dr Bougouin', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}