Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-03-09 @ 7:03 AM
Study NCT ID:
NCT04827160
Status:
COMPLETED
Last Update Posted:
2021-04-01
First Post:
2021-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prediction of Thrombosis Using D-dimer Trends in 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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 280}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-30', 'studyFirstSubmitDate': '2021-03-30', 'studyFirstSubmitQcDate': '2021-03-30', 'lastUpdatePostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'D-dimer trends', 'timeFrame': 'From date of admission until the date of first documented thrombosis or date of death from any cause, or date of intubation whichever came first, assessed up to 1 month', 'description': 'Modifications of D-dimers overtime during the hospitalization'}], 'secondaryOutcomes': [{'measure': 'Thrombosis', 'timeFrame': 'From date of admission until the date of first documented thrombosis or date of death from any cause, or date of intubation whichever came first, assessed up to 1 month', 'description': 'Arterial or venous thrombosis'}, {'measure': 'All-cause mortality', 'timeFrame': 'From date of admission until the date of first documented thrombosis or date of death from any cause, or date of intubation whichever came first, assessed up to 1 month', 'description': 'All-cause mortality'}, {'measure': 'Orotracheal intubation', 'timeFrame': 'From date of admission until the date of first documented thrombosis or date of death from any cause, or date of intubation whichever came first, assessed up to 1 month', 'description': 'Orotracheal intubation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'A high incidence of venous thromboembolic events (VTE) has been demonstrated in COVID-19. This incidence correlates with disease severity. Activation of coagulation secondary to sepsis combined with classical thrombotic risk factors may contribute to this prothrombotic state. Since the beginning of March 2020, the issue of venous thrombosis during SARS-CoV-2 infection has rapidly emerged as a major medical challenge since a significant rate of patients were thrombosing, some of them in spite of a well conducted preventive anticoagulation. Although D-dimers have been shown to be useful in identifying patients at risk of severe COVID-19 and even mortality, they cannot be used for diagnostic exclusion of pulmonary embolism. Indeed, since D-dimer levels rise non-specifically during infectious states, the exclusion threshold of 500 ng/ml cannot be used.\n\nIt would therefore be useful to study the predictive value of D-dimers for thrombosis in COVID-19 patients.', 'detailedDescription': 'Primary outcome : Characterize different D-dimer trends in COVID-19 patients.\n\nSecondary outcomes :\n\n* Identify the predictive value of different D-dimers trends for thrombosis / all-cause mortality / orotracheal intubation during hospitalization\n* Identify the predictive value of D-dimers at admission for thrombosis / all-cause mortality / orotracheal intubation during hospitalization\n* Identify the predictive value of 1st D-dimer/fibrinogen ratio for thrombosis / all-cause mortality / orotracheal intubation during hospitalization'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted at Nancy University Hospital for SARS-CoV-2 infection and with at least one D-dimer result from February 24, 2020 to May 12, 2020.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Positive SARS-CoV-2 PCR and at least one D-dimer result\n\nNon inclusion Criteria: Below 18 yo'}, 'identificationModule': {'nctId': 'NCT04827160', 'acronym': 'TRENDS', 'briefTitle': 'Prediction of Thrombosis Using D-dimer Trends in COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Predictive Value of D-dimers Trends and Levels for Thrombosis in Patients With COVID-19', 'orgStudyIdInfo': {'id': '2020308'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COVID-19', 'description': 'Patients with COVID-19'}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Nancy', 'country': 'France', 'facility': 'CHRU Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Stéphane Zuily', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}