Evidence map›Paper›PMID 33002131›Full record

ArticleBlood advances2020

Safety and efficacy of anticoagulant therapy in pediatric catheter-related venous thrombosis (EINSTEIN-Jr CVC-VTE).

Katharina Thom, Anthonie W A Lensing, Ildar Nurmeev, Fanny Bajolle, Damien Bonnet, Gili Kenet, M Patricia Massicotte, Zeynep Karakas, Joseph S Palumbo, Paola Saracco and 15 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article 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 21 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 5 pooled it
7.0field-weighted citation impact, top 2% 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

21 citing papers in PubMed, 5 syntheses or guidelines pooled it, 49 citations in OpenAlex.

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  13. The value of the old and the new.Blood advances · 2023
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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

25 authors at 16 institutions in 12 countries.

Katharina ThomDepartment of Paediatrics, Medical University of Vienna, Vienna, Austria.
Anthonie W A LensingBayer AG, Wuppertal, Germany.
Ildar NurmeevKazan State Medical University, Kazan, Russia.
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.
Gili KenetSackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
M Patricia MassicotteDepartment of Pediatrics, University of Alberta, Edmonton, AB, Canada.
Zeynep KarakasPediatric Hematology/Oncology, Istanbul Medical Faculty, Istanbul University, Istanbul, Turkey.
Joseph S PalumboCancer and Blood Diseases Institute, Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH.
Paola SaraccoPediatric Hematology, University Hospital Città della Salute e della Scienza, Turin, Italy.
Pascal AmedroPaediatric and Congenital Cardiology Department, M3C Regional Reference Centre, Montpellier University Hospital, PhyMedExp, INSERM, Centre National de la Recherche Scientifique, Montpellier, France.
Juan ChainHospital del Niño Jesus, San Miguel de Tucumán, Argentina.
Anthony K ChanMcMaster Children's Hospital, Hamilton, ON, Canada.
Takanari IkeyamaAichi Children's Health and Medical Center, Aichi, Japan.
Joyce C M LamPaediatric Haematology/Oncology Service, KK Women's and Children's Hospital, Singapore, Singapore.
Cynthia GaugerNemours Children's Specialty Care, Jacksonville, FL.
Ákos Ferenc PapBayer AG, Wuppertal, Germany.
Madhurima MajumderBayer U.S., LLC, Whippany, NJ.
Dagmar KubitzaBayer AG, Wuppertal, Germany.
William T SmithBayer U.S., LLC, Whippany, NJ.
Scott D BerkowitzBayer U.S., LLC, Whippany, NJ.
Martin H PrinsDepartment of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center, Maastricht, The Netherlands.
Paul MonagleDepartment of Clinical Haematology, Royal Children's Hospital, Haematology Research Murdoch Children's Research Institute, Department of Paediatrics, University of Melbourne, Melbourne, VIC, Australia; and.
Guy YoungChildren's Hospital Los Angeles, University of Southern California Keck School of Medicine, Los Angeles, CA.
Christoph MaleDepartment of Paediatrics, Medical University of Vienna, Vienna, Austria.
Bayer (Germany) · DEBayer (United States) · USDélégation Paris 5 · FRMedical University of Vienna · ATAzienda Ospedaliera Citta' della Salute e della Scienza di Torino · ITCentre National de la Recherche Scientifique · FRCincinnati Children's Hospital Medical Center · USIstanbul University · TRKazan State Medical University · RUKK Women's and Children's Hospital · SGMaastricht University · NLMcMaster Children's Hospital · CARoyal Children's Hospital · AUTel Aviv University · ILUniversity of Alberta · CAUniversity of Southern California · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Anticoagulant treatment of pediatric central venous catheter-related venous thromboembolism (CVC-VTE) has not been specifically evaluated. In EINSTEIN-Jr, 500 children with any VTE received rivaroxaban or standard anticoagulants. A predefined analysis of the CVC-VTE cohort was performed. Children with CVC-VTE (age, birth to 17 years) were administered rivaroxaban or standard anticoagulants during the 1-month (children <2 years) or 3-month (all other children) study period. Predefined outcomes were recurrent VTE, change in thrombotic burden on repeat imaging, and bleeding. Predictors for continuation of anticoagulant therapy beyond the study period were evaluated. One hundred twenty-six children with symptomatic (n = 76, 60%) or asymptomatic (n = 50, 40%) CVC-VTE received either rivaroxaban (n = 90) or standard anticoagulants (n = 36). There was no recurrent VTE (0%; 95% confidence interval [CI], 0.0%-2.8%). Three children had the principal safety outcome: none had major bleeding and 3 children had clinically relevant nonmajor bleeding (2.4%; 95% CI, 0.7%-6.5%), all in the rivaroxaban arm. Complete or partial vein recanalization occurred in 57 (55%) and 38 (37%) of 103 evaluable children, respectively. Results were similar for symptomatic and asymptomatic CVC-VTE. Continuation of anticoagulant therapy beyond the study period occurred in 61 (48%) of children and was associated with residual VTE but only in children <2 years (odds ratio [OR], 20.9; P = .003) and continued CVC use (OR, 6.7; P = .002). Anticoagulant therapy appeared safe and efficacious and was associated with reduced clot burden in most children with symptomatic or asymptomatic CVC-VTE. Residual VTE and continued CVC use were associated with extended anticoagulation. This trial was registered at www.clinicaltrials.gov as #NCT02234843.

Indexed as

ThromboembolismVenous ThrombosisAnticoagulantsChildHemorrhageHumansRivaroxabanAnticoagulantsRivaroxaban

Identifiers

PMID33002131
PMCPMC7556137
OpenAlexW3089930892

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.