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COMPLETED
NCT07618988
PHASE4

Rivaroxaban in Pediatric Patients With DVT

Sponsor: Ain Shams University

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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