Rivaroxaban in Pediatric Patients With DVT

Ain Shams University60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pediatric Venous Thromboembolism

Interventions

RivaroxabanDRUG

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, HeparinDRUG

Patients in arm 1 will receive standard anticoagulation with enoxaparin sodium at a dose 1mg/kg twice daily for 3 months duration

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Ain Shams University Children's Hospital

Cairo, Egypt

Outcomes

Primary Outcomes

Degree of vein recanalization

A Repeat site-appropriate imaging at 3 months will be done to assess the degree of vein recanalization and response will be classified as * Normalized: if no residual thrombus is observed, * Improved: if thrombus is still present but partly recanalized or involving less venous segments, * Unchanged: if not recanalized and similar in extent * Deteriorated: if new venous segment involved

Time frame: 3 months

Data from ClinicalTrials.gov

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