Nctid:
NCT06223945
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-03"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000086382", "term"=>"COVID-19"}, {"id"=>"D000018352", "term"=>"Coronavirus Infections"}], "ancestors"=>[{"id"=>"D000011024", "term"=>"Pneumonia, Viral"}, {"id"=>"D000011014", "term"=>"Pneumonia"}, {"id"=>"D000012141", "term"=>"Respiratory Tract Infections"}, {"id"=>"D000007239", "term"=>"Infections"}, {"id"=>"D000014777", "term"=>"Virus Diseases"}, {"id"=>"D000003333", "term"=>"Coronaviridae Infections"}, {"id"=>"D000030341", "term"=>"Nidovirales Infections"}, {"id"=>"D000012327", "term"=>"RNA Virus Infections"}, {"id"=>"D000008171", "term"=>"Lung Diseases"}, {"id"=>"D000012140", "term"=>"Respiratory Tract Diseases"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M2561", "name"=>"COVID-19", "asFound"=>"COVID-19", "relevance"=>"HIGH"}, {"id"=>"M20490", "name"=>"Coronavirus Infections", "asFound"=>"Coronavirus", "relevance"=>"HIGH"}, {"id"=>"M13904", "name"=>"Pneumonia", "relevance"=>"LOW"}, {"id"=>"M13914", "name"=>"Pneumonia, Viral", "relevance"=>"LOW"}, {"id"=>"M14978", "name"=>"Respiratory Tract Infections", "relevance"=>"LOW"}, {"id"=>"M17522", "name"=>"Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M6555", "name"=>"Coronaviridae Infections", "relevance"=>"LOW"}, {"id"=>"M23685", "name"=>"Nidovirales Infections", "relevance"=>"LOW"}, {"id"=>"M15149", "name"=>"RNA Virus Infections", "relevance"=>"LOW"}, {"id"=>"M11168", "name"=>"Lung Diseases", "relevance"=>"LOW"}, {"id"=>"M14977", "name"=>"Respiratory Tract Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["INVESTIGATOR"]}, "primaryPurpose"=>"SUPPORTIVE_CARE", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>1}}, "statusModule"=>{"overallStatus"=>"ACTIVE_NOT_RECRUITING", "startDateStruct"=>{"date"=>"2024-01-12", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2029-01-12", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-24", "studyFirstSubmitDate"=>"2024-01-22", "studyFirstSubmitQcDate"=>"2024-01-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2029-01-12", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"development of an algorithm for the prevention of thrombohemorrhagic complications of COVID-19", "timeFrame"=>"5 years", "description"=>"It is planned to perform a multicenter cohort retrospective study with an expanded analysis of the clinical features of the course, the results of surgical treatment, intensive care, anesthesiological and resuscitation benefits in patients with COVID-19, the course of which was complicated by thrombotic and hemorrhagic complications, including internal and external bleeding from the hollow organs of the abdominal cavity, retroperitoneal space and chest. The material for the study will be formed by combining data from several large clinics, on the basis of which infectious diseases hospitals with a concentration of surgical patients have been deployed. Based on the cumulative assessment of the results obtained, new and improved previously developed surgical and anesthetic-resuscitation algorithms for diagnosis, surgical tactics, intensive care in patients with COVID-19 with thrombotic and hemorrhagic complications in need of surgical and resuscitation procedures will be proposed."}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["COVID-19 (Coronavirus Disease 2019)"]}, "descriptionModule"=>{"briefSummary"=>"The nature of the planned study:\n\nThe topic is of an applied nature and is aimed at improving the results of comprehensive treatment of patients with COVID-19, the course of whose disease was complicated by thrombotic or hemorrhagic catastrophes.\n\nIt is planned to analyze the results of treatment of this category of patients based on the work of several centers that provided surgical care to patients with COVID-19 during the pandemic (8 cities).\n\nAs a result of the analysis, it is planned to develop algorithms for the prevention and treatment of thrombotic and hemorrhagic complications in patients with COVID-19.\n\nThe proposed study will be multicenter, cohort, retrospective.\n\nThe purpose of the study:\n\nImprovement of treatment results in COVID-19 patients with thrombotic or hemorrhagic complications\n\nScientific novelty:\n\nFor the first time, as a result of a multicenter study, it is expected to identify the most effective approach to the treatment and prevention of thrombotic and hemorrhagic complications in patients with COVID-19.\n\nFor the first time, it is planned to develop and put into practice algorithms for the application of the most effective methods of treatment and prevention of thrombohemorrhagic complications of COVID-19."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"90 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Patients with thrombohemorrhagic complications who were treated in a covid hospital\n\nExclusion Criteria:\n\n* Cancer patients\n* Patients who had thrombohemorrhagic disorders before admission to the hospital\n* Pregnant women\n* Patients receiving routine anticoagulant and antiplatelet therapy before admission to the hospital"}, "identificationModule"=>{"nctId"=>"NCT06223945", "briefTitle"=>"Thrombohemorrhagic Complications of COVID-19", "organization"=>{"class"=>"OTHER", "fullName"=>"Volgograd State Medical University"}, "officialTitle"=>"Surgical and Anesthesiological-resuscitation Aspects of Therapeutic Tactics for Thrombotic and Hemorrhagic Complications in Patients With the New Coronavirus Infection COVID-19", "orgStudyIdInfo"=>{"id"=>"12/2024/01/12"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"Thrombotic and hemorrhagic complications of COVID-19", "interventionNames"=>["Diagnostic Test: Prevention algorithm"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Prevention of thrombohemorrhagic complications in COVID-19", "interventionNames"=>["Diagnostic Test: Prevention algorithm"]}], "interventions"=>[{"name"=>"Prevention algorithm", "type"=>"DIAGNOSTIC_TEST", "description"=>"Development of an algorithm for the prevention of thrombohemorrhagic complications", "armGroupLabels"=>["Prevention of thrombohemorrhagic complications in COVID-19", "Thrombotic and hemorrhagic complications of COVID-19"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"400079", "city"=>"Volgograd", "country"=>"Russian Federation", "facility"=>"Clinic №1 of Volgograd State Medical University", "geoPoint"=>{"lat"=>48.71939, "lon"=>44.50183}}], "overallOfficials"=>[{"name"=>"Viktor Mikhin", "role"=>"STUDY_CHAIR", "affiliation"=>"Volgograd State Medical University"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Volgograd State Medical University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
