Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-01-07 @ 12:27 PM
Study NCT ID:
NCT04412304
Status:
COMPLETED
Last Update Posted:
2020-06-22
First Post:
2020-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anticoagulant Therapy and 28-days Mortality in Critically Ill COVID-19 Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D006470', 'term': 'Hemorrhage'}], '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': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017985', 'term': 'Dalteparin'}], 'ancestors': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'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': 166}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-18', 'studyFirstSubmitDate': '2020-05-30', 'studyFirstSubmitQcDate': '2020-05-30', 'lastUpdatePostDateStruct': {'date': '2020-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'D-dimer levels in the three groups groups', 'timeFrame': '28 days from ICU-admission', 'description': 'D-dimer every day it is measured during first 28 days from ICU-admission.'}], 'primaryOutcomes': [{'measure': '28-days ICU mortality', 'timeFrame': '28 days from ICU-admission', 'description': '28-days ICU mortality from admission to the ICU. Discontinue of ICU-care to palliative care counts as death.'}], 'secondaryOutcomes': [{'measure': 'Incidence of thromboembolic events', 'timeFrame': '28 days from ICU-admission', 'description': 'Thromboembolic events are defined as pulmonary emboli (PE), deep venous thrombus (DVT), ischemic stroke and other peripheral arterial emboli. PE is defined as PE verified by computer tomography or by findings of acute strain of the right heart on echocardiography combined with a clinical interpretation of the patients deteriorating as a probable PE stated in the medical records. DVT is defined as DVT verified with ultrasound. Ischemic stroke is defined as ischemic stroke verified by computer tomography. Peripheral arterial emboli are defined as peripheral arterial emboli verified by computer tomography.'}, {'measure': 'Incidence of bleeding events', 'timeFrame': '28 days from ICU-admission', 'description': 'The event of bleeding will be defined by WHO modified bleeding scale as 1-4.'}, {'measure': 'ICU-free days alive from ICU-admission.', 'timeFrame': '28 days from ICU-admission', 'description': 'ICU-free days alive during 28 days from ICU-admission. Counts as 0 days if discharged to ward for palliative treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid-19', 'Thromboembolic Events', 'Bleeding']}, 'referencesModule': {'references': [{'pmid': '33225952', 'type': 'DERIVED', 'citation': 'Jonmarker S, Hollenberg J, Dahlberg M, Stackelberg O, Litorell J, Everhov AH, Jarnbert-Pettersson H, Soderberg M, Grip J, Schandl A, Gunther M, Cronhjort M. Dosing of thromboprophylaxis and mortality in critically ill COVID-19 patients. Crit Care. 2020 Nov 23;24(1):653. doi: 10.1186/s13054-020-03375-7.'}]}, 'descriptionModule': {'briefSummary': 'The aims of the study are to to associate anticoagulation (AC) regime with outcome in critically ill patients with Covid-19. This will be done by describe baseline characteristics and comorbidities before hospital admission, level of organ support and dose of AC treatment and associate this with 28 days survival, survival outside ICU, thromboembolic event and bleeding complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A cohort study of the Covid-19 patients admitted to an ICU at Stockholm South General Hospital from March 6th 2020 to April 30 2020', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* laboratory confirmed positive test for SARS-CoV-2\n* admitted to ICU because of critical illness due to covid-19\n\nExclusion Criteria:\n\n* patients with treatment for thromboembolic complications at arrival to the ICU\n* short ICU length of stay defined as discharged the same or the following day as ICU admission'}, 'identificationModule': {'nctId': 'NCT04412304', 'briefTitle': 'Anticoagulant Therapy and 28-days Mortality in Critically Ill COVID-19 Patients', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Patient Characteristics, Outcome and Thromboembolic Events Among Adult Critically Ill COVID-19 Patients With Different Anticoagulant Regimes at One of the Biggest Emergency Hospitals in Northern Europe, Sweden', 'orgStudyIdInfo': {'id': 'Anticoagulant therapy Covid-19'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'thrombose prophylaxis', 'description': 'The dose used to prevent thromboembolic complication in critically ill', 'interventionNames': ['Drug: Dose of Tinzaparin or Dalteparin']}, {'label': 'double thrombose prophylaxis', 'description': 'Double the dose used to prevent thromboembolic complication in critically ill', 'interventionNames': ['Drug: Dose of Tinzaparin or Dalteparin']}, {'label': 'full dose anticoagulant', 'description': 'Dose used to treat thromboembolic event', 'interventionNames': ['Drug: Dose of Tinzaparin or Dalteparin']}], 'interventions': [{'name': 'Dose of Tinzaparin or Dalteparin', 'type': 'DRUG', 'description': 'The patients will be categorised into three groups depending on initial regime of anticoagulants after arrival in the ICU.', 'armGroupLabels': ['double thrombose prophylaxis', 'full dose anticoagulant', 'thrombose prophylaxis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11880', 'city': 'Stockholm', 'state': 'Stockholm County', 'country': 'Sweden', 'facility': 'South General Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Maria Cronhjort, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet, Department of Clinical Science and Education'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Christer Svensen', 'investigatorAffiliation': 'Karolinska Institutet'}}}}