Trial reportJournal of the American Heart Association2021
Thromboprophylaxis for Children Post-Fontan Procedure: Insights From the UNIVERSE Study.
Trial report in Journal of the American Heart Association, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02846532 (A Prospective, Open-Label, Active-Controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Rivaroxaban for Thromboprophylaxis in Pediatric Subjects 2 to 8 Years of Age After the Fontan Procedure), which is not on this map. Cited by 52 papers, 7 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Prospective, Open-Label, Active-Controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Rivaroxaban for Thromboprophylaxis in Pediatric Subjects 2 to 8 Years of Age After the Fontan Procedure
Who cites it
52 citing papers in PubMed, 7 syntheses or guidelines pooled it.
- Optimal Strategy for Thromboprophylaxis in Fontan Circulation: A Systematic Review and Meta-analysis with a Focus on Ethnic Differences.Pediatric cardiology · 2026Pooled it
- Efficacy and safety of direct oral anticoagulants in pediatric patients: a systematic review and meta-analysis.Frontiers in public health · 2026Pooled it
- Adverse Events of Factor Xa Inhibitors in Pediatric Patients: A Meta-analysis and Pharmacovigilance Study.Paediatric drugs · 2025Pooled it
- Efficacy and safety of antithrombotic therapy for preventing and treating pediatric thromboembolic disease: a systematic review.Scientific reports · 2024Pooled it
- Updated guidance for efficacy and safety outcomes for clinical trials in venous thromboembolism in children: communication from the ISTH SSC Subcommittee on Pediatric and Neonatal Thrombosis and Hemostasis.Journal of thrombosis and haemostasis : JTH · 2023Guideline
- Direct Oral Anticoagulants for Treating Acute Venous Thromboembolism in Children: Meta-Analysis of Randomized Controlled Trials.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/HemostasisPooled it
- Systematic Review of Randomized Clinical Trials on Direct Oral Anticoagulants in Pediatric Heart Diseases.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/HemostasisPooled it
- Antithrombotic Therapy Use in Children With Pulmonary Hypertension.Pulmonary circulation · 2026Article
- Venous Thromboembolism in Neonates, Children, and Adolescents: A Comprehensive Narrative Review of Risk Factors, Diagnosis, Treatment, and Prevention.Medicina (Kaunas, Lithuania) · 2026Review
- Heparin Resistance - A Reality or Fallacy.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2026Article
- Rivaroxaban for extended anticoagulation of pediatric venous thromboembolism.Translational pediatrics · 2026Article
- Outcomes of Fontan Modifications for Isolated Hepatic Vein Drainage: 5 Years Comparative Analysis.Pediatric cardiology · 2026Article
- Outpatient drug therapy for children with heart disease in Switzerland: a survey.European journal of pediatrics · 2026Article
- Efficacy and safety of direct oral anticoagulants in pediatric congenital and acquired heart disease: a systematic review and meta-analysis of randomized controlled trials.Thrombosis journal · 2026Review
- Outcomes of a Physiology-driven Extracardiac Fontan Strategy Incorporating Computational Fluid Dynamics: A Multicentre Study.European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery · 2026Article
- Blood Transfusion Practices in Rural Hospitals: Indications, Challenges, and Practical Solutions.Cureus · 2026Review
- Real-world use of rivaroxaban for primary thromboprophylaxis and cardiac thrombosis treatment in congenital and acquired heart disease: a prospective cohort study.Scientific reports · 2026Article
- Safety of Direct Oral Anticoagulants in Transcatheter Pulmonary Valves: A Pediatric Institution's Experience.Pediatric cardiology · 2026Article
- The use of direct oral anticoagulants in children with congenital and acquired heart disease.Frontiers in cardiovascular medicine · 2026Review
- Rivaroxaban as Secondary Thromboprophylaxis in Pediatric Patients With Short Bowel Syndrome.Case reports in hematology · 2026Article
Corrections and comments
- Erratum issued
Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.