[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07536906":3,"trial-entities:NCT07536906":178,"trial-summary:NCT07536906":183},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":29,"interventions":32,"primary_outcomes":37,"secondary_outcomes":42,"sex":56,"minimum_age":57,"maximum_age":27,"healthy_volunteers":15,"eligibility_criteria":58,"std_ages":69,"locations":71,"central_contacts":169,"overall_officials":172,"references":176,"see_also_links":177},"NCT07536906","202409PJT","Falls Validation Study","Validation of the Falls Decision Rule for Diagnosing Intracranial Bleeding in Older Adults After a Fall","RECRUITING","2030-12-30","2026-05","2026-05-27","2026-05-01","Dr. Kerstin de Wit","OTHER",false,"Each year, one in three adults over the age of 65 has a fall. These falls lead to half a million Canadian emergency department patient visits annually and falls in older adults account for more than 3% of all emergency department visits.\n\nA rapid, simple bedside test (known as a decision rule) to guide emergency physicians on when older adults should have a brain scan to diagnose traumatic brain bleeding was created. This decision rule will be checked to see if it works well in guiding who needs a brain scan.","Traumatic intracranial bleeding is much more prevalent in older adults and has a much worse prognosis as compared to the younger population. Older adults are at risk of traumatic intracranial bleeding because there is loss of the elastic integrity of the cerebral bridging veins and brain atrophy, allowing rapid movements of the brain with trauma. The vast majority of traumatic intracranial bleeding diagnoses in older adults result from low-energy falls from standing or sitting.\n\nIn 2015, the Canadian Medical Association called for a national strategy for older adults that would include evidence-based hospital practices. In 2021-22, older adults accounted for about 25% of all Canadian emergency department visits, and older adults who had fallen account for over 3% of visits. This number continues to rise. A conservative estimation using 2022 Canadian Institute of Health Information data suggests there are at least 500,000 emergency department visits from older adults after a fall annually in Canada, yet there is little research evidence to guide testing for intracranial bleeding.\n\nIt is difficult for physicians to determine the risk of intracranial bleeding when an older patient has fallen. Diagnosing fall-related intracranial bleeding is an important part of the emergency department assessment. It is critical that older patients with intracranial bleeding are identified early so that they are provided with appropriate medical and neurosurgical care\n\nTo address the lack of evidence-based guidance specific to older adults who fall, the Falls Decision Rule was derived to guide the use of brain imaging.\n\nValidation of the Falls Rules would improve image utilization for older adults who have fallen, meaning that intracranial bleeding would be diagnosed on the first emergency department visit. People with very low risk of intracranial bleeding would not need brain imaging which facilitates a faster discharge from the emergency department.",[19,20],"Intracranial Bleed","Falls",[20,22,23,24,25],"Intracranial Bleeding","Head CT","Computed Tomography","Clinical Decision Rule","OBSERVATIONAL",null,[],{"count":30,"type":31},4000,"ESTIMATED",[33],{"type":14,"name":25,"description":34,"armGroupLabels":35},"The Falls Decision Rule will help guide emergency physicians when to obtain brain imaging and when brain imaging is not required.",[36],"Cohort 1",[38],{"measure":39,"description":40,"timeFrame":41},"Clinically Important Intracranial Bleeding","Intracranial bleeding diagnosed at the index emergency department visit or within 30 days. Clinically important intracranial bleeding is defined as bleeding within the cranial vault (including subdural, intracerebral, intraventricular, subarachnoid, epidural blood, and cerebral contusion), which subsequently requires medical or surgical intervention for the bleed or causes death.","30 days",[43,46,49,53],{"measure":44,"description":45,"timeFrame":41},"Clinically Unimportant Intracranial Bleeding","Adjudicated intracranial bleeding within 30 days which does not meet our definition of clinically important.",{"measure":47,"description":48,"timeFrame":41},"Delayed Intracranial Bleeding","Intracranial bleeding diagnosed after the emergency department visit until day 30",{"measure":50,"description":51,"timeFrame":52},"Death","Death within 120 days of the index emergency department visit","120 days",{"measure":54,"description":55,"timeFrame":52},"Recurrent Falls","Evidence that the patient fell at least 1 time after the index emergency department visit.","ALL","65 Years",{"inclusion":59,"exclusion":63,"raw_text":68},[60,61,62],"Age 65 or older","Present to the emergency department within 48 hours of having a fall","Fall from standing, from a chair, toilet seat, or bed",[64,65,66,67],"Transferred from another hospital organization after brain imaging","Leave the emergency department prior to completion of their medical assessment","Previously enrolled","Lives outside the hospital catchment area","Inclusion Criteria:\n\n* Age 65 or older\n* Present to the emergency department within 48 hours of having a fall\n* Fall from standing, from a chair, toilet seat, or bed\n\nExclusion Criteria:\n\n* Transferred from another hospital organization after brain imaging\n* Leave the emergency department prior to completion of their medical assessment\n* Previously enrolled\n* Lives outside the hospital catchment area",[70],"OLDER_ADULT",[72,86,104,116,130,145,156],{"facility":73,"status":74,"city":75,"state":76,"zip":77,"country":78,"contacts":79,"geoPoint":83},"Massachusetts General Hospital","NOT_YET_RECRUITING","Boston","Massachusetts","02115","United States",[80],{"name":81,"role":82},"Shan Liu, MD","PRINCIPAL_INVESTIGATOR",{"lat":84,"lon":85},42.35843,-71.05977,{"facility":87,"status":74,"city":88,"state":89,"zip":90,"country":91,"contacts":92,"geoPoint":101},"Hamilton Health Sciences Corporation","Hamilton","Ontario","L8L 2X2","Canada",[93,99],{"name":94,"role":95,"phone":96,"phoneExt":97,"email":98},"Natasha Clayton","CONTACT","416-566-3590","76207","claytonn@hhsc.ca",{"name":100,"role":82},"Alim Pardhan, MD",{"lat":102,"lon":103},43.25011,-79.84963,{"facility":105,"status":8,"city":106,"state":89,"zip":107,"country":91,"contacts":108,"geoPoint":113},"Kingston Health Sciences Centre","Kingston","K7L 2V7",[109,111],{"name":94,"role":95,"phone":96,"email":110},"natasha.clayton@queensu.ca",{"name":112,"role":82},"Isabelle Gray, MD",{"lat":114,"lon":115},44.22976,-76.48098,{"facility":117,"status":74,"city":118,"state":89,"country":91,"contacts":119,"geoPoint":127},"Ottawa Hospital Research Institute","Ottawa",[120,125],{"name":121,"role":95,"phone":122,"phoneExt":123,"email":124},"Gabriel Sandino-Gold","613-798-5555","17709","gsandino@ohri.ca",{"name":126,"role":82},"Ian Stiell, MD",{"lat":128,"lon":129},45.41117,-75.69812,{"facility":131,"status":74,"city":132,"state":89,"zip":133,"country":91,"contacts":134,"geoPoint":142},"Sinai Health System","Toronto","M5G 1X5",[135,140],{"name":136,"role":95,"phone":137,"phoneExt":138,"email":139},"Cameron Thompson","416-586-4800","3814","cameron.thompson@sinaihealth.ca",{"name":141,"role":82},"Catherine Varner, MD",{"lat":143,"lon":144},43.70643,-79.39864,{"facility":146,"status":74,"city":147,"state":148,"zip":149,"country":91,"contacts":150,"geoPoint":153},"Centre Intégré Universitaire De Santé Et De Services Sociaux Du Nord-De-L'île-De-Montréal,","Montreal","Quebec","H3L 1K5",[151],{"name":152,"role":82},"Justine Lessard, MD",{"lat":154,"lon":155},45.50884,-73.58781,{"facility":157,"status":74,"city":158,"state":148,"country":91,"contacts":159,"geoPoint":166},"CHU de Québec - Université Laval","Québec",[160,165],{"name":161,"role":95,"phone":162,"phoneExt":163,"email":164},"Éric Mercier, MD","418-649-0252","66024","eric.mercier@crchudequebec.ulaval.ca",{"name":161,"role":82},{"lat":167,"lon":168},46.81228,-71.21454,[170],{"name":171,"role":95,"phone":96,"email":110},"Natasha Clayton, Clinical Trial Manager, CRA, RA",[173],{"name":174,"affiliation":175,"role":82},"Kerstin de Wit, MD","Queens University",[],[],{"nct_id":4,"conditions":179,"biomarkers":182},[180,181],"Fall","Intracranial Hemorrhage",[],{"nct_id":4,"found":184,"summary":185,"prompt_version":195},true,{"design":186,"status":187,"heading":188,"summary":189,"follow_up":190,"word_count":191,"commitments":192,"compensation":193,"drugs_mentioned":194},"This is an observational study, meaning researchers will watch and collect information without giving any specific treatment. It plans to include 4000 participants.","completed","Falls Validation Study for Older Adults","This study is looking at a new tool called the Falls Decision Rule. This tool helps emergency doctors decide when older adults who have fallen need a brain scan to check for bleeding in the brain (intracranial bleed). This study wants to see if the Falls Decision Rule works well in guiding these decisions. You might be able to join if you are 65 or older, came to the emergency department within 48 hours of a fall, and fell from a standing position, a chair, toilet, or bed. The main goal is to see how well the rule identifies important brain bleeds within 30 days. The study aims to include 4000 participants, but its current status is unclear.","Participants will be followed to see if they experience a clinically important intracranial bleeding within 30 days.",118,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]