Evidence map›Paper›PMID 33351120›Full record

Trial reportBlood advances2020

Safety and efficacy of rivaroxaban in pediatric cerebral venous thrombosis (EINSTEIN-Jr CVT).

Philip Connor, Mayte Sánchez van Kammen, Anthonie W A Lensing, Elizabeth Chalmers, Krisztián Kállay, Kerry Hege, Paolo Simioni, Tina Biss, Fanny Bajolle, Damien Bonnet and 26 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Blood advances, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02234843 (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), which is not on this map. Cited by 47 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 6 pooled it
4.1field-weighted citation impact, top 4% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT02234843 phase3completednot on this map

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

TypeinterventionalSponsorBayerRan2014 to 2019Enrolled500ConditionsVenous ThromboembolismArmsRivaroxaban (Xarelto, BAY59-7939), Standard of Care
3 · Its place in the literature

Who cites it

47 citing papers in PubMed, 6 syntheses or guidelines pooled it, 105 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Pooled it
  5. Efficacy and Safety of Direct Oral Anticoagulants in Cerebral Venous Thrombosis: Meta-Analysis of Randomized Clinical Trials.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
    Pooled it
  6. Guideline
  7. Trial
  8. Article
  9. Review
  10. Review
  11. Emergency reversal of Rivaroxaban with Andexanet alfa in a child with hemorrhagic brain metastasis from Wilms tumor.Child's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery · 2026
    Article
  12. Review
  13. Observational
  14. Article
  15. Article
  16. Article
  17. Review
  18. Article
  19. Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

36 authors at 20 institutions in 13 countries.

Philip ConnorThe Noah's Ark Children's Hospital for Wales, Cardiff, United Kingdom.
Mayte Sánchez van KammenDepartment of Neurology, Amsterdam University Medical Center (UMC), University of Amsterdam, Amsterdam, The Netherlands.
Anthonie W A LensingBayer AG, Wuppertal, Germany.
Elizabeth ChalmersRoyal Hospital for Children, Glasgow, United Kingdom.
Krisztián KállayDepartment of Pediatric Hematology and Stem Cell Transplantation, Central Hospital of Southern Pest, National Institute of Hematology and Infectious Diseases, Budapest, Hungary.
Kerry HegeRiley Hospital For Children at Indiana University (IU) Health, Indianapolis, IN.
Paolo SimioniThrombotic and Hemorrhagic Diseases Unit, Department of Medicine (DIMED), Padua University Hospital, Padua, Italy.
Tina BissDepartment of Haematology, The Newcastle upon Tyne Hospitals, National Health Service (NHS) Foundation Trust, Newcastle upon Tyne, United Kingdom.
Fanny BajolleM3C-Necker Enfants Malades, Université Paris Descartes, Sorbonne Paris Cité, Paris, France.
Damien BonnetM3C-Necker Enfants Malades, Université Paris Descartes, Sorbonne Paris Cité, Paris, France.
Sebastian GruntDivision of Neuropediatrics, Development, and Rehabilitation, University Children's Hospital, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Riten KumarNationwide Children's Hospital, The Ohio State University, Columbus, OH.
Olga LvovaUral Federal University, Ural State Medical University, Yekaterinburg, Russia.
Rukhmi BhatAnn and Robert H. Lurie Children's Hospital of Chicago, Feinberg School of Medicine, Northwestern University, Chicago, IL.
An Van DammeDepartment of Pediatric Hematology/Oncology, Saint Luc University Hospital, Brussels, Belgium.
Joseph PalumboCancer and Blood Diseases Institute, Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH.
Amparo SantamariaHemostasis and Thrombosis Unit, Department of Hematology, University Hospital Vall d´Hebron, Barcelona, Spain.
Paola SaraccoPediatric Hematology, University Hospital Città della Salute e della Scienza Torino, Turin, Italy.
Jeanette PayneDepartment of Paediatric Haematology, Sheffield Children's Hospital, Sheffield, United Kingdom.
Susan BairdRoyal Hospital for Sick Children, Edinburgh, United Kingdom.
Kamar GodderNicklaus Children's Hospital, Miami, FL.
Veerle LabarqueDepartment of Pediatric Hematology and Oncology, University Hospital Leuven Gasthuisberg, Leuven, Belgium.
Christoph MaleDepartment of Paediatrics, Medical University of Vienna, Vienna, Austria.
Ida MartinelliA. Bianchi Bonomi Hemophilia and Thrombosis Center, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Ca' Granda-Ospedale Maggiore Policlinico, Milan, Italy.
Michelle Morales SotoAntiguo Hospital Civil de Guadalajara Fray Antonio Alcalde, Guadalajara, Mexico.
Jayashree MotwaniBirmingham Children's Hospital, Birmingham, United Kingdom.
Sanjay ShahUniversity of Arizona School of Medicine and Phoenix Children's Hospital, Phoenix, AZ.
Helene L HooimeijerDepartment of Hematology and Oncology, University Medical Center Groningen, Beatrix Children's Hospital, Groningen, The Netherlands.
Martin H PrinsDepartment of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center, Maastricht, The Netherlands.
Dagmar KubitzaBayer AG, Wuppertal, Germany.
William T SmithDepartment of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center, Maastricht, The Netherlands.
Scott D BerkowitzBayer US, LLC, Whippany, NJ; and.
Akos F PapBayer AG, Wuppertal, Germany.
Madhurima MajumderBayer US, LLC, Whippany, NJ; and.
Paul MonagleDepartment of Clinical Haematology, Royal Children's Hospital.
Jonathan M CoutinhoDepartment of Neurology, Amsterdam University Medical Center (UMC), University of Amsterdam, Amsterdam, The Netherlands.
Bayer (Germany) · DEBayer (United States) · USDélégation Paris 5 · FRRoyal Hospital for Children · GBUniversity of Amsterdam · NLAzienda Ospedaliera Citta' della Salute e della Scienza di Torino · ITBirmingham Children's Hospital · GBCincinnati Children's Hospital Medical Center · USCliniques Universitaires Saint-Luc · BEFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico · ITHospital Civil de Guadalajara · MXIndiana University Health · USMaastricht University · NLMedical University of Vienna · ATMiami Children's Hospital · USNational Health Service · GBNationwide Children's Hospital · USNoah's Ark Children's Hospital for Wales · GBNorthwestern University · USRoyal Children's Hospital · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Anticoagulant treatment of pediatric cerebral venous thrombosis has not been evaluated in randomized trials. We evaluated the safety and efficacy of rivaroxaban and standard anticoagulants in the predefined subgroup of children with cerebral venous thrombosis (CVT) who participated in the EINSTEIN-Jr trial. Children with CVT were randomized (2:1), after initial heparinization, to treatment with rivaroxaban or standard anticoagulants (continued on heparin or switched to vitamin K antagonist). The main treatment period was 3 months. The primary efficacy outcome, symptomatic recurrent venous thromboembolism (VTE), and principal safety outcome, major or clinically relevant nonmajor bleeding,were centrally evaluated by blinded investigators. Sinus recanalization on repeat brain imaging was a secondary outcome. Statistical analyses were exploratory. In total, 114 children with confirmed CVT were randomized. All children completed the follow-up. None of the 73 rivaroxaban recipients and 1 (2.4%; CVT) of the 41 standard anticoagulant recipients had symptomatic, recurrent VTE after 3 months (absolute difference, 2.4%; 95% confidence interval [CI], -2.6% to 13.5%). Clinically relevant bleeding occurred in 5 (6.8%; all nonmajor and noncerebral) rivaroxaban recipients and in 1 (2.5%; major [subdural] bleeding) standard anticoagulant recipient (absolute difference, 4.4%; 95% CI, -6.7% to 13.4%). Complete or partial sinus recanalization occurred in 18 (25%) and 39 (53%) rivaroxaban recipients and in 6 (15%) and 24 (59%) standard anticoagulant recipients, respectively. In summary, in this substudy of a randomized trial with a limited sample size, children with CVT treated with rivaroxaban or standard anticoagulation had a low risk of recurrent VTE and clinically relevant bleeding. This trial was registered at clinicaltrials.gov as #NCT02234843.

Indexed as

Venous ThromboembolismVenous ThrombosisAnticoagulantsChildHemorrhageHumansRivaroxabanAnticoagulantsRivaroxaban

Identifiers

PMID33351120
PMCPMC7756994
OpenAlexW3111817205

What OpenQuestion holds

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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.