Rivaroxaban for Intracardiac Thrombosis in the Pediatric Population

Intracardiac Thrombus Clinical Trial

Official title:

Rivaroxaban for Intracardiac Thrombosis in the Pediatric Population at Different Cardiac Sites

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06371170
• Other study ID #: CCPC- 001/22
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: January 1, 2027

Study information

• Verified date: April 2024
• Source: Azienda Ospedaliero, Universitaria Ospedali Riuniti
• Contact: Francesco Bianco, M.D., Ph.D.
• Phone: +39 071 5965283
• Email: francesco.bianco[@]ospedaliriuniti.marche.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Intracardiac Thrombus
• Thrombosis

Intervention

Drug:
• Rivaroxaban
Oral anticoagulation

Locations

Country	Name	City	State
Italy	CCPC	Ancona	Marche

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero, Universitaria Ospedali Riuniti

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Agarwal S, Abdelghani E, Stanek JR, Sankar A, Cua CL, Kerlin BA, Rodriguez V. Intracardiac thrombi in pediatrics: anticoagulation approach and treatment outcomes. Res Pract Thromb Haemost. 2023 Nov 24;7(8):102266. doi: 10.1016/j.rpth.2023.102266. eCollection 2023 Nov. — View Citation

Male C, Lensing AWA, Palumbo JS, Kumar R, Nurmeev I, Hege K, Bonnet D, Connor P, Hooimeijer HL, Torres M, Chan AKC, Kenet G, Holzhauer S, Santamaria A, Amedro P, Chalmers E, Simioni P, Bhat RV, Yee DL, Lvova O, Beyer-Westendorf J, Biss TT, Martinelli I, Saracco P, Peters M, Kallay K, Gauger CA, Massicotte MP, Young G, Pap AF, Majumder M, Smith WT, Heubach JF, Berkowitz SD, Thelen K, Kubitza D, Crowther M, Prins MH, Monagle P; EINSTEIN-Jr Phase 3 Investigators. Rivaroxaban compared with standard anticoagulants for the treatment of acute venous thromboembolism in children: a randomised, controlled, phase 3 trial. Lancet Haematol. 2020 Jan;7(1):e18-e27. doi: 10.1016/S2352-3026(19)30219-4. Epub 2019 Nov 5. — View Citation

Nellis ME, Tucci M, Lacroix J, Spinella PC, Haque KD, Stock A, Steiner ME, Faustino EVS, Zantek ND, Davis PJ, Stanworth SJ, Cholette JM, Parker RI, Demaret P, Kneyber MCJ, Russell RT, Stricker PA, Vogel AM, Willems A, Josephson CD, Luban NLC, Loftis LL, Leteurtre S, Stocker CF, Goobie SM, Karam O; Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network; and the Pediatric Critical Care Blood Research Network (BloodNet). Bleeding Assessment Scale in Critically Ill Children (BASIC): Physician-Driven Diagnostic Criteria for Bleeding Severity. Crit Care Med. 2019 Dec;47(12):1766-1772. doi: 10.1097/CCM.0000000000004025. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thrombus resolution	Rate of intracardiac thrombus resolution at CMR/CCT imaging	3 months
Secondary	Bleeding	Rate of major bleeding utilizing the BASIC bleeding score	3 months