[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564407":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":38,"responsibleParty":57,"collaborators":59,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":18,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":18,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":86,"whyStopped":18,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Johns Hopkins All Children's Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"EnoxaparinThromboprophylaxis","EXPERIMENTAL","This arm will receive the study intervention, enoxaparin thromboprophylaxis during pediatric intensive care unit hospitalization",[13],"Drug: Enoxaparin",{"label":15,"type":16,"description":17,"interventionNames":18},"No Pharmacological Thromboprophylaxis","NO_INTERVENTION","This arm will receive no pharmacological thromboprophylaxis",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","Enoxaparin","Enoxaparin thromboprophylaxis administered subcutaneously twice daily (every 12 hours) from enrollment through pediatric intensive care unit discharge",[9],[26],{"name":27,"affiliation":5,"role":28},"Anthony Sochet, MD, MSc","PRINCIPAL_INVESTIGATOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":18,"email":34},"Anthony A Sochet, MD, MSc","CONTACT","727-767-2912","sochet@jhmi.edu",{"name":36,"role":32,"phone":33,"phoneExt":18,"email":37},"Neil A Goldenberg, MD, Phd","neil@jhmi.edu",[39],{"facility":40,"status":18,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Johns Hopkins All Children\"s Hospital","St. Petersburg","Florida","33704","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-82.67927,27.77086,{"lat":50,"lon":49},[53,56],{"name":54,"role":32,"phone":33,"phoneExt":18,"email":55},"Anthony A Sochet","Sochet@jhmi.edu",{"name":31,"role":28,"phone":18,"phoneExt":18,"email":18},{"type":58,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[60],{"name":61,"class":6},"University of California, San Diego","100564407","phase-3-collaborative-risk-stratified-investigation-in-thrombosis-prone-inpatients-with-critical-illness-anticoagulation-with-lmwh-in-teens-for-thromboprophylaxis-critical-teens-tp-100564407",false,"NCT06628778","Collaborative Risk-stratified Investigation in Thrombosis-prone Inpatients With Critical Illness: Anticoagulation With LMWH in Teens for ThromboProphylaxis (CRITICAL-Teens-TP).","Collaborative Risk-stratified Investigation in Thrombosis-prone Inpatients With Critical Illness: Anticoagulation With LMWH in Teens for ThromboProphylaxis (CRITICAL-Teens-TP)","Inclusion Criteria:\n\n* Admission Age between 12- 18 years of age\n* Within 24 hours of pediatric intensive care unit (PICU) admission for enrollment\n* Presence of a Central Venous Catheter\n* Presumed or confirmed infection or systemic inflammatory condition\n\nExclusion Criteria:\n\n* Active treatment for VTE or known VTE present prior to or on pediatric intensive care unit (PICU) admission\n* Current receipt of an antithrombotic agent excluding unfractionated heparin for vascular catheter patency\n* Active ISTH-defined clinically relevant bleeding\n* Surgery in the last 7-days\n* Major trauma within the last 7-days\n* Admission for management of congenital heart disease including perioperative management of critical congenital heart disease\n* Presence of coagulopathy including:\n* International normalized ratio (INR) 2.0 activated partial thromboplastin time (aPTT) 50 seconds Platelet count 50 x103\u002FmL\n* Creatinine clearance 30 ml\u002Fmin\u002F1.73 m2\n* Known hypersensitivity to heparin or pork products\n* Laboratory confirmed heparin induced thrombocytopenia\n* Current pregnancy or lactation,\n* Presence of an epidural catheter\n* Prior enrollment in the CRITICAL-Teens-TP Trial","ALL","12 Years","18 Years",{"count":73,"type":74},802,"ESTIMATED","INTERVENTIONAL",[77],"PHASE3","Critically ill adolescents are at greatest risk for developing hospital-acquired venous thromboembolism. To date, no phase 3 randomized controlled trials have been conducted for pharmacological thromboprophylaxis as primary venous thromboembolism prevention in children. The investigators will perform a United States definitive multicenter phase 3 randomized controlled trial of the low molecular weight heparin enoxaparin as primary venous thromboembolism prophylaxis among critically ill adolescents who are classified a priori as high risk based upon the investigators validated risk prediction models.",[80],"Venous Thromboembolism (VTE)",[82,83,84,85],"pediatric","adolescent","critical illness","thromboprophylaxis","NOT_YET_RECRUITING","2026-05-21",{"date":89,"type":90},"2026-05-26","ACTUAL",{"date":92,"type":74},"2027-04-15",{"date":94,"type":74},"2035-04-15",{"name":5,"class":6},1]