[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525432":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":31,"responsibleParty":49,"collaborators":20,"id":53,"slug":20,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":20,"eligibilityCriteria":57,"healthyVolunteers":54,"sex":58,"minAge":59,"maxAge":20,"enrollmentInfo":60,"targetDuration":20,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":20,"overallStatus":33,"whyStopped":20,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"APPRAISE cases","EXPERIMENTAL","Trauma patients for which APPRAISE system was used",[13],"Device: APPRAISE Trauma Clinical Decision Support System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","APPRAISE Trauma Clinical Decision Support System","Real-time bedside decision-support system for trauma patient management",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Andrew Reisner, MD","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Iain Kehoe","CONTACT","6177262241","ikehoe@mgh.harvard.edu",[32],{"facility":5,"status":33,"city":34,"state":35,"zip":36,"country":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"RECRUITING","Boston","Massachusetts","02460","United States",{"type":39,"coordinates":40},"Point",[41,42],-71.05977,42.35843,{"lat":42,"lon":41},[45],{"name":46,"role":28,"phone":47,"phoneExt":20,"email":48},"Andrew T Reisner","617-726-2241","areisner@mgh.harvard.edu",{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"SPONSOR_INVESTIGATOR","Andrew Tomas Reisner","Principal Investigator; Associate Prof. of Emergency Medicine","100525432",false,"NCT06121661","APPRAISE 2.0: Live Trial of the APPRAISE Trauma Decision Support System","Inclusion Criteria:\n\n* Adult (≥18 yrs) Emergency Department (ED) patient\n* Triaged to the \"Acute\" area of the ED. (The \"Acute\" area is the designated area for ED patients with potential or established critical illness. Triage to Acute is a routine ED operation that is performed based on departmental guidelines and the professional judgement of an experienced triage nurse).\n* Clinical concern for acute injury (based on either an explicitly chief complaint of acute injury, or clinical team with documented concern for acute injury as a relevant part of patient presentation).\n\nExclusion Criteria:\n\n* Prisoners\n* Patients known to be pregnant, based on patient report, physical exam, or bedside ultrasound\n* Patients wearing an \"EFIC Opt-Out\" bracelet\n* Any concern about the suitability of the software system for a specific patient by any clinician involved in the patient's ED care, or by the patient themselves (or by any LAR \\[lawfully authorized representative\\] of the patient).","ALL","18 Years",{"count":61,"type":62},20,"ESTIMATED","INTERVENTIONAL",[65],"PHASE1","This is a pilot evaluation of the APPRAISE trauma decision-support software system (\"the System\"). The specific objections are as follows:\n\n1. Evaluate the robustness of the System (i.e., whether the software performs in real-time in accordance with a priori technical specifications during real-time clinical use);\n2. Evaluate whether the real-time display of the System causes distraction or confusion to clinicians treating the trauma patient such that its risks exceed its benefits;\n3. Collect pilot data to allow for a statistical power analysis to design a future clinical trial evaluating efficacy.",[68],"Wounds and Injuries","2025-05-05",{"date":71,"type":72},"2025-05-08","ACTUAL",{"date":74,"type":72},"2023-02-21",{"date":76,"type":62},"2028-12-14",{"name":51,"class":6},1]