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Collaborative Risk-stratified Investigation in Thrombosis-prone Inpatients With Critical Illness: Anticoagulation With LMWH in Teens for ThromboProphylaxis (CRITICAL-Teens-TP).
Sponsor: 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.
Official title: Collaborative Risk-stratified Investigation in Thrombosis-prone Inpatients With Critical Illness: Anticoagulation With LMWH in Teens for ThromboProphylaxis (CRITICAL-Teens-TP)
Key Details
Gender
All
Age Range
12 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
802
Start Date
2027-04-15
Completion Date
2035-04-15
Last Updated
2026-05-26
Healthy Volunteers
No
Conditions
Interventions
Enoxaparin
Enoxaparin thromboprophylaxis administered subcutaneously twice daily (every 12 hours) from enrollment through pediatric intensive care unit discharge
Locations (1)
Johns Hopkins All Children"s Hospital
St. Petersburg, Florida, United States