Nctid:
NCT06614478
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000073496", "term"=>"Frailty"}, {"id"=>"D000050723", "term"=>"Fractures, Bone"}, {"id"=>"D000006620", "term"=>"Hip Fractures"}], "ancestors"=>[{"id"=>"D000014947", "term"=>"Wounds and Injuries"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000005264", "term"=>"Femoral Fractures"}, {"id"=>"D000025981", "term"=>"Hip Injuries"}, {"id"=>"D000007869", "term"=>"Leg Injuries"}], "browseLeaves"=>[{"id"=>"M1175", "name"=>"Frailty", "asFound"=>"Frailty", "relevance"=>"HIGH"}, {"id"=>"M9696", "name"=>"Hip Fractures", "asFound"=>"Hip Fracture", "relevance"=>"HIGH"}, {"id"=>"M26370", "name"=>"Fractures, Bone", "asFound"=>"Fracture", "relevance"=>"HIGH"}, {"id"=>"M17685", "name"=>"Wounds and Injuries", "relevance"=>"LOW"}, {"id"=>"M8402", "name"=>"Femoral Fractures", "relevance"=>"LOW"}, {"id"=>"M23105", "name"=>"Hip Injuries", "relevance"=>"LOW"}, {"id"=>"M10881", "name"=>"Leg Injuries", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Wounds and Injuries", "abbrev"=>"BC26"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>200}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2023-04-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2026-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-23", "studyFirstSubmitDate"=>"2024-09-23", "studyFirstSubmitQcDate"=>"2024-09-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-12-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Frailty status", "timeFrame"=>"preoperatively", "description"=>"Frailty will be categorized based on the validated Groningen Frailty Indicator (GFI) as non-frail (NF, score 0,1), pre-frail (PF, score 2, 3) and severe frail (SF, score \\>4)."}, {"measure"=>"Inflammatory biomarkers", "timeFrame"=>"preoperatively", "description"=>"Upon admission and immediate before surgery upper limits of white blood cells (WBC) within normal range (WBC \\>8 10\\^3/μL), NLR (neutrophils/lymphocytes), PLR (platelets/lymphocytes), CRP (C-reactive protein) and CLR (CRP/lymphocytes), will be recorded."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Frailty", "Hip Fracture", "Inflammatory Biomarkers"]}, "descriptionModule"=>{"briefSummary"=>"We ought to investigate if hip fracture patients suffering from frailty have higher inflammatory burden according to simple inflammatory biomarkers.", "detailedDescription"=>"Frailty (F) is a prevalent syndrome among elderly patient with hip fractures (HF) and has been linked to poor prognosis. Inflammatory biomarkers have been used as prognostic indexes in patients with HF. We ought to investigate if hip fracture patients suffering from frailty have higher inflammatory burden according to simple inflammatory biomarkers."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["OLDER_ADULT"], "minimumAge"=>"65 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"hip fracture patients treated with surgery", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* age \\>65 years, ASA PS I-III, non- institutionalized, able to communicate patients\n\nExclusion Criteria:\n\n* Patients with severe cognitive dysfunction, those treated conservatively, those with pathological fractures and patients who refused to participate"}, "identificationModule"=>{"nctId"=>"NCT06614478", "briefTitle"=>"Frailty, Hip Fractures and Inflammatory Biomarkers", "organization"=>{"class"=>"OTHER", "fullName"=>"University of Thessaly"}, "officialTitle"=>"Frailty in Hip Fracture Patients Treated With Surgery; the Role of Simple Inflammatory Biomarkers. An Observational Study", "orgStudyIdInfo"=>{"id"=>"Frailty and hip fractures"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"hip fracture patients treated with surgery", "description"=>"Hip fracture patients treated with surgery. Frailty will be categorized based on the validated Groningen Frailty Indicator (GFI)"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"41110", "city"=>"Larissa", "state"=>"Thessaly", "status"=>"RECRUITING", "country"=>"Greece", "contacts"=>[{"name"=>"Eleni Arnaoutoglou, Professor", "role"=>"CONTACT", "email"=>"earnaout@gmail.com", "phone"=>"030241302952"}], "facility"=>"Larissa University Hospital", "geoPoint"=>{"lat"=>39.63689, "lon"=>22.41761}}, {"zip"=>"41110", "city"=>"Larissa", "state"=>"Thessaly", "status"=>"RECRUITING", "country"=>"Greece", "contacts"=>[{"name"=>"Eleni Arnaoutoglou, Professor", "role"=>"CONTACT", "email"=>"earnaout@gmail.com", "phone"=>"+30241302952"}, {"name"=>"Maria Ntalouka, MD, PhD, Mac", "role"=>"CONTACT", "email"=>"maria.ntalouka@icloud.com"}], "facility"=>"UHL", "geoPoint"=>{"lat"=>39.63689, "lon"=>22.41761}}], "centralContacts"=>[{"name"=>"Eleni Arnaoutoglou, Professor", "role"=>"CONTACT", "email"=>"earnaout@gmail.com", "phone"=>"+302413502952"}, {"name"=>"Maria Ntalouka, MD, PhD, Mac", "role"=>"CONTACT"}], "overallOfficials"=>[{"name"=>"Eleni Arnaoutoglou, Professor", "role"=>"STUDY_CHAIR", "affiliation"=>"University of Thessaly"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University of Thessaly", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Chair, Professor of Anaesthesiology", "investigatorFullName"=>"Elena Arnaoutoglou", "investigatorAffiliation"=>"University of Thessaly"}}}}
