Rivaroxaban for Intracardiac Thrombosis in the Pediatric Population
Rivaroxaban for Intracardiac Thrombosis in the Pediatric Population at Different Cardiac Sites
Azienda Ospedaliero, Universitaria Ospedali Riuniti
20 participants
Jan 1, 2023
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria2
- Intracardiac thrombosis demonstration at echocardiography and CMR/CCT confirmation
- Given informed consent from the parents or tutors
Exclusion Criteria4
- < 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
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Interventions
Oral anticoagulation
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06371170