Collaborative Risk-stratified Investigation in Thrombosis-prone Inpatients With Critical Illness: Anticoagulation With LMWH in Teens for ThromboProphylaxis (CRITICAL-Teens-TP)
Johns Hopkins All Children's Hospital
Summary
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.
Description
This trial will establish definitive evidence on the comparative efficacy and safety of pharmacological thromboprophylaxis with the low molecular weight heparin (LMWH) enoxaparin versus no pharmacological thromboprophylaxis for the primary prevention of venous thromboembolism (VTE), including deep vein thrombosis and/or pulmonary embolism) among critically ill adolescents who meet a priori criteria for high risk of hospital-acquired (HA-) VTE. In the past two decades, the diagnosis of pediatric hospital-acquired VTE (HA-VTE) in the U.S. has increased 130-200-fold. The investigators have shown…
Eligibility
- Age range
- 12–18 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Major trauma within t…
Interventions
- DrugEnoxaparin
Enoxaparin thromboprophylaxis administered subcutaneously twice daily (every 12 hours) from enrollment through pediatric intensive care unit discharge
Location
- Johns Hopkins All Children"s HospitalSt. Petersburg, Florida