GuidelineJournal of thrombosis and haemostasis : JTH2023
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.
Guideline in Journal of thrombosis and haemostasis : JTH, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 2 of them syntheses that pooled it.
What it found
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
14 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- ASH/ISTH 2026 guidelines for anticoagulant prophylaxis in pediatric patients at risk of venous thromboembolism.Blood advances · 2026Guideline
- Incidence of neonatal venous thromboembolism: a systematic review and meta-analysis of the literature.Research and practice in thrombosis and haemostasis · 2026Pooled it
- Evaluation of Enoxaparin Dosing in Infants Greater Than 2 to 6 Months of Age, a Pre and Post Quasi Experiment.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2026Article
- 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
- Analysis of risk factors and prognostic differences in hospital-acquired thrombosis between very preterm infants and moderate to late preterm infants.Frontiers in pediatrics · 2026Article
- Evaluating the Impact of an Institutional Practice Change from Warfarin to Therapeutic Rivaroxaban Post-Fontan Operation.Pediatric cardiology · 2025Article
- Rivaroxaban in Chinese children with giant coronary artery aneurysms after Kawasaki disease.Research and practice in thrombosis and haemostasis · 2025Article
- Intermittent pneumatic compression thromboprophylaxis among critically ill children: a single-center retrospective cohort study.Research and practice in thrombosis and haemostasis · 2025Article
- Recurrent thrombosis and major bleeding in children treated for VTE.Blood advances · 2025Article
- The balancing act after pediatric venous thromboembolism.Blood advances · 2025Article
- High- and intermediate-risk pulmonary embolism in pediatric tertiary care centers in the Netherlands.Research and practice in thrombosis and haemostasis · 2025Article
- Pediatric Venous Thromboembolism: Considerations for the Interventional Radiologist.Seminars in interventional radiology · 2025Review
- Procedural outcomes in children with mild type 1 von Willebrand disease.Research and practice in thrombosis and haemostasis · 2024Article
- Improving Anticoagulation Care for Pediatric Oncology Patients: A Quality Improvement Initiative.Pediatric quality & safetyArticle
Corrections and comments
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Authors and funding
10 authors.
Funding
Abstract
Despite the growing number of pediatric antithrombotic clinical trials, standardized safety and efficacy outcome definitions for pediatric venous thromboembolism (VTE) clinical trials have not been updated since 2011. Many recent trials have adapted the recommended definitions, leading to heterogeneity in outcomes and limiting our ability to compare studies. The International Society on Thrombosis and Haemostasis Scientific and Standardization Subcommittee (SSC) on Pediatric and Neonatal Thrombosis and Hemostasis organized a Task Force to update the efficacy and safety outcome definitions for pediatric VTE clinical trials. The outcome definitions used in the recent pediatric antithrombotic trials, definitions recommended for adult studies, and regulatory guidelines were summarized and reviewed by the Task Force as the basis for this updated guidance. Major updates to the efficacy outcomes include the removal of VTE-related mortality as a part of a composite primary outcome and explicit inclusion of all deep venous anatomic sites. Safety outcomes were updated to include a new bleeding severity category: patient important bleeding, no intervention, which encompasses bleeding for which a patient seeks care but there is no change in management. Menstrual bleeding can now be included in any bleeding category when the criteria are met. We hope that these updated outcome definitions will allow the investigators to focus on clinically relevant and patient-important outcomes and provide standardization to facilitate continued high-quality evidence for the use of antithrombotic therapies in children.
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