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Thromboprophylaxis for Children Post-Fontan Procedure: Insights From the UNIVERSE Study
Brian W McCrindle1, Alan D Michelson2, Andrew H Van Bergen3
1The Hospital for Sick Children University of Toronto Toronto ON Canada.
Insights
Rivaroxaban showed a similar safety profile and fewer thrombotic events compared to aspirin in children after the Fontan procedure. This study evaluated rivaroxaban
Area of Science:
- Cardiology
- Pediatric Medicine
- Pharmacology
Background:
- Patients with single-ventricle physiology undergoing the Fontan procedure face high risks of thrombotic events, leading to significant morbidity and mortality.
- The UNIVERSE Study investigated a novel liquid rivaroxaban formulation for thromboprophylaxis in these high-risk pediatric patients.
- Acetylsalicylic acid (ASA) served as the comparator in this comprehensive clinical evaluation.
Purpose of the Study:
- To evaluate the efficacy and safety of a body weight-adjusted dosing regimen of liquid rivaroxaban.
- To compare rivaroxaban against acetylsalicylic acid (ASA) for thromboprophylaxis in children post-Fontan procedure.
- To assess the pharmacokinetic/pharmacodynamic profile and safety of rivaroxaban in this specific pediatric population.
Main Methods:
- A randomized, multicenter, 2-part, open-label study (UNIVERSE Study) involving 112 participants across 10 countries.
- Part A: Assessed pharmacokinetics/pharmacodynamics and safety of rivaroxaban in 12 participants.
- Part B: Randomized 100 participants 2:1 to receive either open-label rivaroxaban or ASA for 12 months.
Main Results:
- Safety: Major bleeding occurred in one participant on rivaroxaban; clinically relevant nonmajor bleeding was 6% (rivaroxaban) vs. 9% (ASA); trivial bleeding was 33% vs. 35%.
- Efficacy: One participant on rivaroxaban experienced pulmonary embolism (2% event rate).
- Efficacy: One participant on ASA had ischemic stroke, and two had venous thrombosis (9% event rate).
Conclusions:
- Rivaroxaban demonstrated a comparable safety profile to ASA in pediatric patients post-Fontan procedure.
- Fewer thrombotic events were observed in the rivaroxaban group compared to the ASA group, although not statistically significant.
- The findings suggest rivaroxaban is a potential alternative for thromboprophylaxis in children following the Fontan procedure.
Abstract:
Background Patients with single-ventricle physiology who undergo the Fontan procedure are at risk for thrombotic events associated with significant morbidity and mortality. The UNIVERSE Study evaluated the efficacy and safety of a novel liquid rivaroxaban formulation, using a body weight-adjusted dosing regimen, versus acetylsalicylic acid (ASA) in children post-Fontan. Methods and Results The UNIVERSE Study was a randomized, multicenter, 2-part, open-label study of rivaroxaban, in children who had undergone a Fontan procedure, to evaluate its dosing regimen, safety, and efficacy. Part A was the single-arm part of the study that determined the pharmacokinetics/pharmacodynamics and safety of rivaroxaban in 12 participants before proceeding to part B, whereby 100 participants were randomized 2:1 to open-label rivaroxaban versus ASA. The study period was 12 months. A total of 112 participants were enrolled across 35 sites in 10 countries. In part B, for safety outcomes, major bleeding occurred in one participant on rivaroxaban (epistaxis that required transfusion). Clinically relevant nonmajor bleeding occurred in 6% of participants on rivaroxaban versus 9% on ASA. Trivial bleeding occurred in 33% of participants on rivaroxaban versus 35% on ASA. For efficacy outcomes, 1 participant on rivaroxaban in part B had a pulmonary embolism (2% overall event rate); and for ASA, 1 participant had ischemic stroke and 2 had venous thrombosis (9% overall event rate). Conclusions In this study, participants who received rivaroxaban for thromboprophylaxis had a similar safety profile and fewer thrombotic events, albeit not statistically significant, compared with those in the ASA group. Registration URL: https://www.clinicaltrials.gov. Identifier: NCT02846532.
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