Rivaroxaban for Intracardiac Thrombosis in the Pediatric... | NCT06371170

Studies
Rivaroxaban for Intracardiac Thrombosis in the Pediatric Population

NCT06371170

Sponsor

Azienda Ospedaliero, Universitaria Ospedali Riuniti

Status

Recruiting

Last Update Posted

Apr 19, 2024Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Intracardiac Thrombus

Interventions

Rivaroxaban

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2023Actual

Primary Completion Date

Jan 1, 2025Estimated

Completion Date

Jan 1, 2027Estimated

First Submitted Date

Apr 15, 2024

First Submission Date that Met QC Criteria

Apr 15, 2024

First Posted Date

Apr 17, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2024

Last Update Posted Date

Apr 19, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Francesco Bianco, Principal Investigator, Azienda Ospedaliero, Universitaria Ospedali RiunitiPrincipal Investigator

Lead Sponsor

Azienda Ospedaliero, Universitaria Ospedali RiunitiOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rivaroxaban	Drug	Oral anticoagulation		Xarelto

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Thrombus resolution	Rate of intracardiac thrombus resolution at CMR/CCT imaging	3 months

Secondary Outcomes

Measure	Description	Time Frame
Bleeding	Rate of major bleeding utilizing the BASIC bleeding score	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

16 Years

Standard Ages

Child

Study Population

Pediatric patients (neonates and pediatrics) diagnosed with intracardiac thrombosis at any possible cardiac site (right/left ventricle, right/left atria, or auricola).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Francesco Bianco, M.D., Ph.D.	Contact	+39 071 5965283		francesco.bianco@ospedaliriuniti.marche.it
Valentina Bucciarelli, M.D., Ph.D.	Contact	+39 071 5965283		valentina.bucciarelli@ospedaliriuniti.it

Overall Officials

Name	Affiliation	Role
Francesco Bianco, M.D., Ph.D.	AOU - Ospedali Riuniti Ancona	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CCPC	Recruiting	Ancona	The Marches	60123	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
8225659	Background	Ozkutlu S, Ozbarlas N, Ozme S, Saraclar M, Gogus S, Demircin M. Intracardiac thrombosis diagnosed by echocardiography in childhood: predisposing and etiological factors. Int J Cardiol. 1993 Jul 15;40(3):251-6. doi: 10.1016/0167-5273(93)90008-5.
20305543	Background	Yang JY, Williams S, Brandao LR, Chan AK. Neonatal and childhood right atrial thrombosis: recognition and a risk-stratified treatment approach. Blood Coagul Fibrinolysis. 2010 Jun;21(4):301-7. doi: 10.1097/MBC.0b013e3283333c7c.

ID	Term
D013876	Thiophenes
D013457	Sulfur Compounds
D009930	Organic Chemicals
D009025	Morpholines