Collaborative Risk-stratified Investigation in Thrombosis-prone Inpatients With Critical Illness: Anticoagulation With LMWH in Teens for ThromboProphylaxis (CRITICAL-Teens-TP).

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.

Timeline

Start

2027-04-15

Primary completion

2034-04-15

Completion

2035-04-15

Publications

• Sochet AA, Amankwah EK, Andalib V, Jaffray J, Male C, Faustino EV, Goldenberg NA; Pedi-ATLAS Group and the Antithrombotic Trials Working Party of the Pediatric Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Enhanced trial efficiency of the novel "contemporaneous control recapture" parallel-cohort RCT design: Methods and application in the CRITICAL-Kids-TP trial. Contemp Clin Trials. 2026 Jan;160:108142. doi: 10.1016/j.cct.2025.108142. Epub 2025 Nov 10.

Drugs

Indications