NCT06371170

Rivaroxaban for Intracardiac Thrombosis in the Pediatric Population

Rivaroxaban for Intracardiac Thrombosis in the Pediatric Population at Different Cardiac Sites

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Azienda Ospedaliero, Universitaria Ospedali Riuniti · Academic / Other
• Sex: All
• Age: 1 Month – 16 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to determine the efficacy of rivaroxaban treatment for intracardiac thrombi resolution in pediatric patients (\< 16 years old) diagnosed with intracardiac thrombosis. The main question it aims to answer is: Does rivaroxaban treatment resolve the thrombosis during a 3-month treatment? Participants already taking rivaroxaban as part of their regular medical care for thrombosis resolution. They will undergo monthly visits to check that the treatment is progressing correctly and that no major bleeding has occurred. After 3 months of treatment, they will repeat the radiological imaging investigation to verify the actual resolution of the thrombosis.

Detailed description

The Investigators will enroll all the consecutive pediatric patients (\< 16 years old) treated with rivaroxaban (dosage based on patient's body weight - 0.9 mg/Kg/Day) due to intracardiac thrombosis (ICT) suspected by echocardiography and confirmed with cardiac computed tomography (CCT) or magnetic resonance (CMR) imaging. All the participants will be treated with enoxaparin for 7 days before the rivaroxaban implementation. The treatment will last for 3 months. The participants will undergo monthly visits to check that the treatment is progressing correctly and that no major bleeding has occurred. Bleeding severity will be assessed utilizing the Bleeding Assessment Scale in Critically Ill Children (BASIC). CCT/CMR will be repeated to confirm the thrombosis resolution. After 3 months of treatment, they will repeat the radiological imaging investigation to verify the effective resolution of the thrombosis, or it will be continued for another 3 months if there is no resolution of the thrombosis.

Conditions

• Intracardiac Thrombus

Interventions

Type	Name	Description
DRUG	Rivaroxaban	Oral anticoagulation

Timeline

• Start date: 2023-01-01
• Primary completion: 2025-01-01
• Completion: 2027-01-01
• First posted: 2024-04-17
• Last updated: 2024-04-19

Locations

1 site across 1 country: Italy