ArticleThrombosis journal2018
Rivaroxaban versus standard anticoagulation for acute venous thromboembolism in childhood. Design of the EINSTEIN-Jr phase III study.
Article in Thrombosis journal, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 18 papers, 3 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.
Multicenter, Open-label, Active-controlled, Randomized Study to Evaluate the Efficacy and Safety of an age-and Body Weight-adjusted Rivaroxaban Regimen Compared to Standard of Care in Children With Acute Venous Thromboembolism
Safety and Efficacy of Rivaroxaban in Pediatric Patients With Deep Venous Thrombosis
Who cites it
18 citing papers in PubMed, 3 syntheses or guidelines pooled it, 40 citations in OpenAlex.
- Adverse Events of Factor Xa Inhibitors in Pediatric Patients: A Meta-analysis and Pharmacovigilance Study.Paediatric drugs · 2025Pooled it
- Oral direct thrombin inhibitors or oral factor Xa inhibitors versus conventional anticoagulants for the treatment of deep vein thrombosis.The Cochrane database of systematic reviews · 2023Pooled it
- Oral direct thrombin inhibitors or oral factor Xa inhibitors versus conventional anticoagulants for the treatment of pulmonary embolism.The Cochrane database of systematic reviews · 2023Pooled it
- Dosing Regimen Prediction and Confirmation With Rivaroxaban for Thromboprophylaxis in Children After the Fontan Procedure: Insights From the Phase III UNIVERSE Study.Journal of clinical pharmacology · 2022Trial
- Safety and efficacy of rivaroxaban in pediatric cerebral venous thrombosis (EINSTEIN-Jr CVT).Blood advances · 2020Trial
- Direct oral anticoagulant rivaroxaban for secondary prevention of catheter-related thrombosis in children with intestinal failure: real-life data.Research and practice in thrombosis and haemostasis · 2025Article
- Antiphospholipid syndrome presenting as isolated renal vein thrombosis: a case report and review of the literature.Journal of medical case reports · 2025Review
- Pharmacokinetics of a microdosed cocktail of three direct oral anticoagulants in children with congenital heart defects: study protocol for a single-centre clinical trial (DOAC-Child).BMJ paediatrics open · 2023Article
- Model-informed bridging of rivaroxaban doses for thromboprophylaxis in pediatric patients aged 9 years and older with congenital heart disease.CPT: pharmacometrics & systems pharmacology · 2022Article
- Current Antithrombotic Therapy Strategies in Children with a Focus on Off-Label Direct Oral Anticoagulants-A Narrative Review.Children (Basel, Switzerland) · 2022Review
- Direct oral anticoagulants in pediatric venous thromboembolism: Review of approved products rivaroxaban and dabigatran.Frontiers in pediatrics · 2022Review
- Challenges in Management of VTE in Children With Cancer: Risk Factors and Treatment Options.Frontiers in pediatrics · 2022Review
- Population pharmacokinetic analysis of rivaroxaban in children and comparison to prospective physiologically-based pharmacokinetic predictions.CPT: pharmacometrics & systems pharmacology · 2021Article
- Safety and efficacy of anticoagulant therapy in pediatric catheter-related venous thrombosis (EINSTEIN-Jr CVC-VTE).Blood advances · 2020Article
- Venous Thromboembolism in Children: From Diagnosis to Management.International journal of environmental research and public health · 2020Review
- Direct Oral Anticoagulants: Novel Approach for the Treatment of Thrombosis in Pediatric Patients?Pediatric cardiology · 2019Review
- Rivaroxaban and the EINSTEIN clinical trial programme.Blood coagulation & fibrinolysis : an international journal in haemostasis and thrombosis · 2019Review
- Clinical presentation and therapeutic management of venous thrombosis in young children: a retrospective analysis.Thrombosis journal · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors at 12 institutions in 8 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundVenous thromboembolism (VTE) is a relatively rare condition in childhood with treatment mainly based on extrapolation from studies in adults. Therefore, clinical trials of anticoagulation in children require novel approaches to deal with numerous challenges. The EINSTEIN-Jr program identified pediatric rivaroxaban regimens commencing with in vitro dose finding studies followed by evaluation of children of different ages through phase I and II studies using extensive modeling to determine bodyweight-related doses. Use of this approach resulted in drug exposure similar to that observed in young adults treated with rivaroxaban 20 mg once-daily.
methodsEINSTEIN-Jr phase III is a randomized, open-label, study comparing the efficacy and safety of rivaroxaban 20 mg-equivalent dose regimens with those of standard anticoagulation for the treatment of any types of acute VTE in children aged 0-18 years.A total of approximately 500 children are expected to be included during the 4-year study window. Flexibility of treatment duration is allowed with study treatment to be given for 3 months with the option to continue treatment in 3-month increments, up to a total of 12 months. However, based on most common current practice, children younger than 2 years with catheter-related thrombosis will have a main treatment period of 1 month with the option to prolong treatment in 1-month increments, up to a total of 3 months.
conclusionsEINSTEIN-Jr will compare previously established 20 mg-equivalent rivaroxaban dosing regimens with standard anticoagulation for the treatment of VTE in children. Demonstration of similarity of disease, as well as equivalent rivaroxaban exposure and exposure-response will enable extrapolation of efficacy from adult trials, which is critical given the challenges of enrollment in pediatric anticoagulation trials.
trial registrationClinicaltrials.gov NCT02234843, registered on 9 September 2014.
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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.