Collaborative Risk-stratified Investigation in Thrombosis-prone Inpatients With Critical Illness:… (NCT06628778) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Collaborative Risk-stratified Investigation in Thrombosis-prone Inpatients With Critical Illness: Anticoagulation With LMWH in Teens for ThromboProphylaxis (CRITICAL-Teens-TP).
United States802 participantsStarted 2027-04-15
Plain-language 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.
Who can participate
Age range
12 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 the last 7-days
* Admission for management of congenital heart disease including perioperative management of critical congenital heart disease
* Presence of coagulopathy including:
* 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
* Known hypersensitivity to heparin or pork products
* Laboratory confirmed heparin induced thrombocytopenia
* Current pregnancy or lactation,
* Presence of an epidural catheter
* Prior enrollment in the CRITICAL-Teens-TP Trial
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Risk (i.e., cumulative incidence) of Symptomatic venous thromboembolism
Timeframe: From randomization through discharge from the pediatric intensive care unit, approximately 1-2 weeks
2
Risk (i.e., cumulative incidence) of Clinically relevant bleeding
Timeframe: From randomization through discharge from the pediatric intensive care unit, approximately 1-2 weeks