Prospective interventional randomized controlled trial to assess safety and efficacy of rivaroxaban in pediatric patients with acute deep venous thrombosis.

Treatment of deep venous thrombotic events in children is based on data obtained in adults with little direct documentation of its efficacy and safety in children. Rivaroxaban is a direct oral anticoagulant which has been approved by FDA in 2021 for the use in pediatric patients with venous thrombosis.

In a randomized controlled trial we will study the safety and efficacy of rivaroxaban use in the pediatric population with acute deep venous thrombosis.

Inclusion Criteria:

1. Patients from 6 months to less than 18 years of age.
2. Patients with acute deep venous thrombosis diagnosed based on site-appropriate imaging tools e.g., magnetic resonance venography (MRV) in Cerebral sinus venous thrombosis (CSVT), venous duplex in Central Venous Access Devices (CVAD) related thrombosis or other non-CSVT DVT.
3. Patients with cancer associated thrombosis are eligible.
4. Patients with provoked or unprovoked acute VT are eligible.
5. Patients with first thrombotic event or recurrent VT are eligible.

Exclusion Criteria:

1. Patients with active bleeding

2. High-risk of bleeding including:

   • Platelet count of less than 50 x 109/L,
   • Liver disease associated either a coagulopathy leading to a clinically relevant bleeding risk, or ALT > 5× ULN.
   • Sustained uncontrolled hypertension defined as systolic and/or diastolic blood pressure > 95th age percentile.

3. Severe renal impairment (Estimated glomerular filtration rate < 30 mL/min/1.73m2).

4. Gastrointestinal disease associated with impaired absorption.

5. Hypersensitivity or any other contraindication listed in the local labelling for Rivaroxaban or comparator treatment.

6. Patients with rheumatic heart disease or prosthetic heart valves.