Actively Recruiting
Rivaroxaban for Intracardiac Thrombosis in the Pediatric Population
Led by Azienda Ospedaliero, Universitaria Ospedali Riuniti · Updated on 2024-04-19
20
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Rivaroxaban for Intracardiac Thrombosis in the Pediatric Population
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Intracardiac thrombosis confirmed by echocardiography and cardiac MRI or CT scan
- Informed consent given by parents or legal guardians
You will not qualify if you...
- Born before 38 weeks of gestation
- Oral feeding for less than 10 days or body weight below 2.6 kg
- Any major or clinically relevant bleeding event or abnormal coagulation test results within 10 days before enrollment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
CCPC
Ancona, The Marches, Italy, 60123
Actively Recruiting
Research Team
F
Francesco Bianco, M.D., Ph.D.
CONTACT
V
Valentina Bucciarelli, M.D., Ph.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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