Rivaroxaban for Intracardiac Thrombosis in the Pediatric Population

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-16
SponsorAzienda Ospedaliero, Universitaria Ospedali Riuniti

About this trial

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.

Eligibility criteria

Qualifiers

Intracardiac thrombosis demonstration at echocardiography and CMR/CCT confirmation

Given informed consent from the parents or tutors

Disqualifiers

< 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

Trial design

Treatments tested in this trial

  • Rivaroxaban

Treatment groups

No treatment groups listed