Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06371170
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-15
Brief Title:
Rivaroxaban for Intracardiac Thrombosis in the Pediatric Population
Sponsor:
Azienda Ospedaliero Universitaria Ospedali Riuniti
Organization:
Azienda Ospedaliero Universitaria Ospedali Riuniti
Study Overview
Official Title:
Rivaroxaban for Intracardiac Thrombosis in the Pediatric Population at Different Cardiac Sites
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 patients body weight - 09 mgKgDay 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 CCTCMR 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
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 CCTCMR 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None