Nctid:
NCT06233851
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000001930", "term"=>"Brain Injuries"}, {"id"=>"D000070642", "term"=>"Brain Injuries, Traumatic"}, {"id"=>"D000001924", "term"=>"Brain Concussion"}], "ancestors"=>[{"id"=>"D000001927", "term"=>"Brain Diseases"}, {"id"=>"D000002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}, {"id"=>"D000006259", "term"=>"Craniocerebral Trauma"}, {"id"=>"D000020196", "term"=>"Trauma, Nervous System"}, {"id"=>"D000014947", "term"=>"Wounds and Injuries"}, {"id"=>"D000016489", "term"=>"Head Injuries, Closed"}, {"id"=>"D000014949", "term"=>"Wounds, Nonpenetrating"}], "browseLeaves"=>[{"id"=>"M5207", "name"=>"Brain Injuries", "asFound"=>"Brain Injury", "relevance"=>"HIGH"}, {"id"=>"M628", "name"=>"Brain Injuries, Traumatic", "asFound"=>"Traumatic Brain Injury", "relevance"=>"HIGH"}, {"id"=>"M5201", "name"=>"Brain Concussion", "asFound"=>"Mild Traumatic Brain Injury", "relevance"=>"HIGH"}, {"id"=>"M24734", "name"=>"Post-Concussion Syndrome", "relevance"=>"LOW"}, {"id"=>"M5204", "name"=>"Brain Diseases", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"M17685", "name"=>"Wounds and Injuries", "relevance"=>"LOW"}, {"id"=>"M9349", "name"=>"Craniocerebral Trauma", "relevance"=>"LOW"}, {"id"=>"M22023", "name"=>"Trauma, Nervous System", "relevance"=>"LOW"}, {"id"=>"M18892", "name"=>"Head Injuries, Closed", "relevance"=>"LOW"}, {"id"=>"M17687", "name"=>"Wounds, Nonpenetrating", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Wounds and Injuries", "abbrev"=>"BC26"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"bioSpec"=>{"retention"=>"SAMPLES_WITHOUT_DNA", "description"=>"blood sample"}, "studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>600}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2020-10-06", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2025-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-30", "studyFirstSubmitDate"=>"2024-01-16", "studyFirstSubmitQcDate"=>"2024-01-30", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-10", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"intracranial injuries on CT scan", "timeFrame"=>"Admission; within 24 hours", "description"=>"Hemorrhage, oedema, traumatic infarction, diffuse axonal injury, pneumocephalus"}, {"measure"=>"Post concussion symptoms", "timeFrame"=>"3 months", "description"=>"Such as persistent headache, fatigue, concentration difficulty etc. Evaluated by a neuropsychologist and results of the PCSI score (post concussion symptoms inventory)"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Mild Traumatic Brain Injury"]}, "descriptionModule"=>{"briefSummary"=>"The goal of this observational study is to identify blood biomarkers that could help in the management of paediatric patients with mild TBI. The main questions it aims to answer are:\n\n1. How can blood biomarkers reduce unnecessary CT scan and reduce the length of stay at the emergency department?\n2. How can blood biomarker predict post-concussion symptoms?\n\nParticipants will have a blood sample taken when they are admitted at emergency department and will receive a questionnaire describing their symptoms 14 days and 3 months after their trauma.", "detailedDescription"=>"Mild Traumatic Brain Injury (mTBI) in children is a very frequent reason for presentation at the paediatric emergency department. In most cases, the trauma will not lead to intracranial lesions. The first objective for clinicians is therefore to detect all children in need of neurosurgical intervention after mTBI. Although computerized tomography (CT) is currently the modality of choice for acute intracranial haemorrhage identification, care should be taken to avoid unnecessary exposure to ionizing radiation in the developing brain. Monitoring the occurrence of bleeding usually involves an observation period which generally extends from six to twenty-four hours. This time is stressful for the child and parents as well as time and cost consuming for the hospital. In addition to the acute conditions, it has been described that post-concussion symptoms can occur in the weeks or months following the trauma, and neuropsychological follow-up of these children could help prevent or reduce the symptoms. The aim of our study is to find biomarkers that can identify children with clinically important intracranial injury and/or children that will eventually suffer from a post-concussion syndrome."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD"], "maximumAge"=>"16 years", "minimumAge"=>"0 months", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"paediatric patient suffering from a mild TBI within 24 hours", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* mTBI within 24 hours\n\nExclusion Criteria:\n\n* refusal of child or parents\n* evidence of intoxication with alcohol or other substances\n* history of TBI ( less than one month)\n* epilepsy, encephalitis, meningitis, melanoma"}, "identificationModule"=>{"nctId"=>"NCT06233851", "acronym"=>"t-BIOMAP", "briefTitle"=>"t-BIOMAP : Prospective Paediatric Cohort Study of Blood Biomarkers in mTBI", "organization"=>{"class"=>"OTHER", "fullName"=>"Pediatric Clinical Research Platform"}, "officialTitle"=>"Prospective Paediatric Cohort Study of Biomarkers in the Early Management of Mild Traumatic Brain Injury and Prediction of Persistent Post-concussion Symptoms", "orgStudyIdInfo"=>{"id"=>"2020-01533"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"mTBI patient", "description"=>"Children \\<16 years-old who suffered a head trauma in the last 24 hours with signs of mild traumatic brain injury"}, {"label"=>"control", "description"=>"Children \\<16 years-old who have a scheduled blood test for any reason"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"1211", "city"=>"Geneve", "status"=>"RECRUITING", "country"=>"Switzerland", "contacts"=>[{"name"=>"Anne-Cécile CHIOLLAZ, PharmD", "role"=>"CONTACT", "email"=>"sergio.manzano@hcuge.ch", "phone"=>"+41223795894"}, {"name"=>"Sergio MANZANO, MD", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"HUG", "geoPoint"=>{"lat"=>46.20222, "lon"=>6.14569}}], "centralContacts"=>[{"name"=>"Anne-Cécile CHIOLLAZ, PharmD", "role"=>"CONTACT", "email"=>"anne-cecile.chiollaz@unige.ch", "phone"=>"+41223795894"}, {"name"=>"Sergio Manzano, MD", "role"=>"CONTACT", "email"=>"sergio.manzano@hcuge.ch"}], "overallOfficials"=>[{"name"=>"Sergio Manzano, MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"University Hospital, Geneva"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Pediatric Clinical Research Platform", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"professor", "investigatorFullName"=>"Sergio MANZANO", "investigatorAffiliation"=>"Pediatric Clinical Research Platform"}}}}
