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.
Admission Age between 12- 18 years of age
Within 24 hours of pediatric intensive care unit (PICU) admission for enrollment
Presence of a Central Venous Catheter
Presumed or confirmed infection or systemic inflammatory condition
Active treatment for VTE or known VTE present prior to or on pediatric intensive care unit (PICU) admission
Current receipt of an antithrombotic agent excluding unfractionated heparin for vascular catheter patency
Active ISTH-defined clinically relevant bleeding
Surgery in the last 7-days
Johns Hopkins All Children's Hospital
Lead sponsor
University of California, San Diego
Collaborator