Evidence map›Paper›PMID 39461724›Full record

Trial reportJournal of thrombosis and haemostasis : JTH2025

Duration of anticoagulation for venous thromboembolism in pediatric patients: Evaluation of the Duration of Therapy for Thrombosis in Children (Kids-DOTT) trial outcomes at 2 years.

Neil A Goldenberg, Sam Schulman, John M Kittelson, Thomas C Abshire, James F Casella, Rita Dale, Jonathan L Halperin, Jade Hanson, Craig M Kessler, Marilyn J Manco-Johnson and 6 more

Abstract readMulticenter StudyRandomized Controlled TrialEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of thrombosis and haemostasis : JTH, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Guideline
  2. Trial
  3. Review
  4. Endovascular Management of Pediatric Deep Venous Thrombosis.Seminars in interventional radiology · 2025
    Review
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

16 authors.

Neil A GoldenbergJohns Hopkins All Children's Institute for Clinical and Translational Research, Johns Hopkins All Children's Hospital, St. Petersburg, Florida, USA; Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA. Electronic address: neil@jhmi.edu.
Sam SchulmanDepartment of Medicine, Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, Ontario, Canada; Department of Cardiology, Obstetrics and Gynecology and Perinatal Medicine, I.M. Sechenov First Moscow State Medical University, Moscow, Russia.
John M KittelsonDepartment of Biostatistics, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA; CPC Clinical Research, Aurora, Colorado, USA.
Thomas C AbshireDepartment of Pediatrics and Medicine, Clinical & Translational Science Institute, Versiti Blood Research Institute, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
James F CasellaDepartment of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Rita DaleDepartment of Biostatistics, Worldwide Clinical Trials, Research Triangle Park, North Carolina, USA.
Jonathan L HalperinThe Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Jade HansonJohns Hopkins All Children's Institute for Clinical and Translational Research, Johns Hopkins All Children's Hospital, St. Petersburg, Florida, USA.
Craig M KesslerDepartment of Medicine, Georgetown University School of Medicine, Lombardi Comprehensive Cancer Center, Washington, D.C., USA.
Marilyn J Manco-JohnsonDepartment of Pediatrics, School of Medicine, Children's Hospital of Colorado, Hemophilia and Thrombosis Center, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.
Laurel McDevittJohns Hopkins All Children's Institute for Clinical and Translational Research, Johns Hopkins All Children's Hospital, St. Petersburg, Florida, USA.
Robert F SidonioDepartment of Pediatrics, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, Georgia, USA.
Alex C SpyropoulosDepartment of Medicine, Zucker School of Medicine at Hofstra/Northwell, Feinstein Institutes for Medical Research, Manhasset, New York, USA.
P Gabriel StegDepartment of Cardiology, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, French Alliance for Cardiovascular Trials, Institut National de la Santé et de la Recherche Médicale 1148, Université Paris-Cité, Paris, France.
Marc P BonacaCPC Clinical Research, Aurora, Colorado, USA; Division of Cardiology, School of Medicine, University of Colorado Denver Anschutz Medical Campus, Aurora, Colorado, USA.
Multicenter Evaluation of the Duration of Therapy for Thrombosis in Children (Kids-DOTT) Trial Investigators and the Antithrombotic Trials Leadership and Steering (ATLAS) Group

Funding

KidsDOTT-CCCU01HL130048 · NHLBI · JOHNS HOPKINS UNIVERSITY · PI GOLDENBERG, NEIL A · 2016 to 2021
$3.1M
Clinical Investigation in Pediatric ThrombosisK23HL084055 · NHLBI · UNIVERSITY OF COLORADO DENVER · PI GOLDENBERG, NEIL A · 2007 to 2011
$743k
NHLBI NIH HHS K23 HL084055NHLBI NIH HHS U01 HL130048
6 · The paper itself

Abstract

backgroundThe Multicenter Evaluation of the Duration of Therapy for Thrombosis in Children multinational, randomized clinical trial revealed noninferiority of a 6-week vs 3-month duration of anticoagulation for the treatment of provoked venous thromboembolism (VTE) in patients <21 years old in regard to net clinical benefit at 1 year.

objectivesTo evaluate noninferiority at 2 years.

methodsPatients whose repeat imaging 6 weeks after VTE diagnosis did not show complete veno-occlusion were randomized to discontinue anticoagulation vs receive a total 3-month course and followed for 2 years for the occurrence of symptomatic recurrent VTE (efficacy outcome) and clinically relevant bleeding (safety outcome). Outcomes were centrally adjudicated, and net clinical benefit was compared between treatment arms via a prespecified bivariate noninferiority boundary, using 95% CIs in absolute risk differences between treatment arms.

resultsKaplan-Meier estimates of 2-year cumulative incidences in the 6-week and 3-month arms of the intention-to-treat population (n = 417) were 1.7% (95% CI, 0%, 3.7%) and 2.9% (95% CI, 0.3%, 5.4%), respectively, for symptomatic recurrent VTE and 1.1% (95% CI, 0%, 2.5%) and 3.2% (95% CI, 0.6%, 5.7%), respectively, for clinically relevant bleeding. Bivariate analysis of the absolute risk differences in the intention-to-treat population demonstrated that a 6-week anticoagulation duration was noninferior to a 3-month course.

conclusionThese findings support durability of the Kids-DOTT randomized clinical trial findings of net clinical benefit at 2 years.

Indexed as

AnticoagulantsVenous ThromboembolismAdolescentAge FactorsChildChild, PreschoolDrug Administration ScheduleDuration of TherapyFemaleHemorrhageHumansInfantMaleRecurrenceRisk FactorsTime FactorsAnticoagulantsanticoagulationchildrendurationtreatmentvenous thromboembolism

Identifiers

PMID39461724
PMCPMC11786982

What OpenQuestion holds

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Registered trials

None linked

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.