Collaborative Risk-stratified Investigation in Thrombosis-prone Inpatients With Critical Illness: Anticoagulation With LMWH in Teens for ThromboProphylaxis (CRITICAL-Teens-TP).
Key facts
- Who runs it
- Johns Hopkins All Children's Hospital
- Where
- St. Petersburg, United StatesSee the site
- Trial code
- Status
- Not yet recruiting
- Phase
- Phase 3
- People taking part
- 802 people, planned
- Starts
- 15 Apr 2027
- Expected to end
- 15 Apr 2035
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Enoxaparin
- Record updated
- 26 May 2026
Who can take part
- Age
- 12 years to 18 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- 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
Who cannot take part
- Active treatment for VTE or known VTE present prior to or on pediatric intensive care unit (PICU) admission
- Surgery in the last 7-days
- Prior enrollment in the CRITICAL-Teens-TP Trial
- Active ISTH-defined clinically relevant bleeding
- Admission for management of congenital heart disease including perioperative management of critical congenital heart disease
- Known hypersensitivity to heparin or pork products
- International normalized ratio (INR) 2.0 activated partial thromboplastin time (aPTT) 50 seconds Platelet count 50 x103/mL
- Creatinine clearance 30 ml/min/1.73 m2
- Laboratory confirmed heparin induced thrombocytopenia
- Current receipt of an antithrombotic agent excluding unfractionated heparin for vascular catheter patency
- Major trauma within the last 7-days
- Presence of coagulopathy including:
- Current pregnancy or lactation,
- Presence of an epidural catheter
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 12 and 18 years old?
Where in United States
- Johns Hopkins All Children's HospitalSt. Petersburg, United StatesContact: Anthony A SochetNot yet recruiting
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- EnoxaparinThromboprophylaxisTreatment being tested
This arm will receive the study intervention, enoxaparin thromboprophylaxis during pediatric intensive care unit hospitalization
Treatment: Enoxaparin
- No Pharmacological ThromboprophylaxisNo study treatment, for comparison
This arm will receive no pharmacological thromboprophylaxis
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Collaborative Risk-stratified Investigation in Thrombosis-prone Inpatients With Critical Illness: Anticoagulation With LMWH in Teens for ThromboProphylaxis (CRITICAL-Teens-TP)
- Fit questions
- Built from NCT06628778, who can take part
- Record updated
- 26 May 2026