Rivaroxaban in Paediatric Patients Beyond Clinical Trial Settings – A Real-World Retrospective Cohort Study

Hamostaseologie
DOI: 10.1055/a-2918-8110

Authors Author Affiliations

Lukas Röthlisberger

1   Department of Haematology, University Children's Hospital Zürich (Ringgold ID: RIN30995), Zürich, ZH, Switzerland

2   Faculty of Medicine, University of Zurich (Ringgold ID: RIN27217), Zürich, ZH, Switzerland

Manuela Albisetti

1   Department of Haematology, University Children's Hospital Zürich (Ringgold ID: RIN30995), Zürich, ZH, Switzerland

Alessandra Bosch

1   Department of Haematology, University Children's Hospital Zürich (Ringgold ID: RIN30995), Zürich, ZH, Switzerland


Supported by: Filling the gap program, University of Zurich, Switzerland Supported by: Children’s Research Centre of the University Children’s Hospital Zurich, Switzerland Supported by: Walter and Gertraud Siegenthaler Foundation, University of Zurich, Switzerland Supported by: Claus Cramer Foundation
A.B. is supported by research grants from the “Claus Cramer Foundation,” “Filling the gap program” and “Walter and Gertraud Siegenthaler Foundation” from the University of Zurich, Switzerland, and by the Children’s Research Centre of the University Children’s Hospital Zurich, Switzerland. Further Information(opens Publication History section)Also available at  SFX Search Buy Article(opens in new window) Permissions and Reprints(opens in new window) Article preview thumbnailAbstract

Background Direct oral anticoagulants (DOACs) show increasing popularity in the treatment of paediatric venous thromboembolism (VTE), but real-world evidence outside clinical trials remains scarce.

Objectives This study aimed to evaluate the use, safety and effectiveness of rivaroxaban in a real-world paediatric cohort at a tertiary care hospital.

Methods All children exposed to rivaroxaban between January 2020 and June 2025 at our institution were included into this single-centre retrospective cohort study. In chart reviews, effectiveness was assessed as thrombus recurrence, progression, resolution, or improvement; safety outcomes included clinically relevant bleeding (CRB) and minor bleeding.

Results Fifty-seven children were included at a median age of 13.8 years (IQR 7.1–15.6); 49% were female. In the treatment group (n = 37), one thrombosis recurred (3%), with thrombus resolution in 19 (54%) and radiologic improvement in 5 patients (14%). In the prophylaxis group (n = 20), no incident VTE occurred. Overall, CRB was rare (7%), all non-major during rivaroxaban exposure and occurred exclusively in children with identifiable additional bleeding risk factors.

Conclusions Rivaroxaban demonstrated a favourable effectiveness and safety profile in this real-world paediatric cohort, with outcomes comparable to available real-world and trial data. CRB events clustered in settings with additional bleeding risks, underscoring the importance of patient characteristics in guiding therapy. Our findings support rivaroxaban as a feasible anticoagulation option in children.

Keywords adolescent - child - infant - rivaroxaban - venous thromboembolism Publication History

Received: 08 May 2026

Accepted after revision: 17 July 2026

Article published online:
29 July 2026

© 2026. Thieme. All rights reserved.

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