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Rivaroxaban in Pediatric Patients With DVT
Sponsor: Ain Shams University
Summary
Prospective interventional randomized controlled trial to assess safety and efficacy of rivaroxaban in pediatric patients with acute deep venous thrombosis.
Official title: Safety and Efficacy of Rivaroxaban in Pediatric Patients With Deep Venous Thrombosis
Key Details
Gender
All
Age Range
6 Months - 18 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2024-08-03
Completion Date
2026-05-01
Last Updated
2026-06-01
Healthy Volunteers
No
Conditions
Interventions
Rivaroxaban
Patients allocated to Rivaroxaban arm: after 5 to 9 days of therapy with low molecular weight heparin (LMWH), patients will receive body weight-adjusted 20-mg equivalent doses with an age-appropriate serving of fluid given with or shortly after a meal. Crushed Rivaroxaban tablet is stable for up to 4 hours and displays similar relative bioavailability compared to a whole tablet administered orally.
Enoxaparin, Heparin
Patients in arm 1 will receive standard anticoagulation with enoxaparin sodium at a dose 1mg/kg twice daily for 3 months duration
Locations (1)
Ain Shams University Children's Hospital
Cairo, Egypt