Rivaroxaban for Intracardiac Thrombosis in the Pediatric Population

Recruiting

• Conditions: Intracardiac Thrombus

• Registration Number: NCT06371170
• Lead Sponsor: Azienda Ospedaliero, Universitaria Ospedali Riuniti

Brief 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.

Study Timeline

• Study Start: 2023-01-01
• Status Verified: 2024-04
• Study First Submitted: 2024-04-15
• Study First Submitted QC: 2024-04-15
• Study First Posted: 2024-04-17
• Last Update Submitted: 2024-04-17
• Last Update Posted: 2024-04-19
• Primary Completion: 2025-01-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Intracardiac thrombosis demonstration at echocardiography and CMR/CCT confirmation
• Given informed consent from the parents or tutors

Exclusion Criteria

• < 38 weeks of gestational birth
• < 10 days of oral feeding and body weight
• < 2.6 Kg
• Any major or clinically relevant bleeding event or abnormal coagulation test results within 10 days prior to the enrollment for the whole population

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Thrombus resolution	3 months	Rate of intracardiac thrombus resolution at CMR/CCT imaging

Secondary Outcome Measures

Name	Time	Method
Bleeding	3 months	Rate of major bleeding utilizing the BASIC bleeding score

Trial Locations

Locations (1)

CCPC; 🇮🇹 Ancona, Marche, Italy