Trial reportBlood2020
Safety of dabigatran etexilate for the secondary prevention of venous thromboembolism in children.
Trial report in Blood, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 40 papers, 6 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.
Open-label, Randomized, Parallel-group, Active-controlled, Multi-centre Non-inferiority Study of Dabigatran Etexilate Versus Standard of Care for Venous Thromboembolism Treatment in Children From Birth to Less Than 18 Years of Age
Open Label, Single Arm Safety Prospective Cohort Study of Dabigatran Etexilate for Secondary Prevention of Venous Thromboembolism in Children From 0 to Less Than 18 Years
Who cites it
40 citing papers in PubMed, 6 syntheses or guidelines pooled it, 90 citations in OpenAlex.
- Efficacy and safety of direct oral anticoagulants in pediatric patients: a systematic review and meta-analysis.Frontiers in public health · 2026Pooled it
- American Society of Hematology/International Society on Thrombosis and Haemostasis 2024 updated guidelines for treatment of venous thromboembolism in pediatric patients.Blood advances · 2025Guideline
- Direct oral anticoagulants versus standard anticoagulation in children treated for acute venous thromboembolism.Pediatric research · 2023Pooled it
- Direct oral anticoagulant safety during breastfeeding: a narrative review.European journal of clinical pharmacology · 2021Pooled it
- Direct Oral Anticoagulants for Treating Acute Venous Thromboembolism in Children: Meta-Analysis of Randomized Controlled Trials.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/HemostasisPooled it
- Systematic Review of Randomized Clinical Trials on Direct Oral Anticoagulants in Pediatric Heart Diseases.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/HemostasisPooled it
- Venous Thromboembolism in Neonates, Children, and Adolescents: A Comprehensive Narrative Review of Risk Factors, Diagnosis, Treatment, and Prevention.Medicina (Kaunas, Lithuania) · 2026Review
- Heparin Resistance - A Reality or Fallacy.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2026Article
- Rivaroxaban in Chinese children with giant coronary artery aneurysms after Kawasaki disease.Research and practice in thrombosis and haemostasis · 2025Article
- The balancing act after pediatric venous thromboembolism.Blood advances · 2025Article
- Secondary Anticoagulation Use in Patients < 21 Years Old following Primary Anticoagulant Treatment for Provoked Venous Thromboembolism: Findings from the Kids-DOTT Trial.Seminars in thrombosis and hemostasis · 2025Article
- Successful rivaroxaban and doxycycline therapy forFrontiers in pediatrics · 2025Article
- Anticoagulant prescribing trends, bleeding events, and reversal agent use in pediatric patients: A retrospective, real-world study.PloS one · 2025Article
- Decoding Pulmonary Embolism: Pathophysiology, Diagnosis, and Treatment.Biomedicines · 2024Review
- Incidence, Management, and Outcomes of Pulmonary Embolism at Tertiary Pediatric Hospitals in the United States.JACC. Advances · 2024Article
- Dabigatran for Treatment and Secondary Prevention of Venous Thromboembolism in Pediatric Congenital Heart Disease.Journal of the American Heart Association · 2024Article
- Article
- The value of the old and the new.Blood advances · 2023Article
- Real-world use of apixaban for the treatment and prevention of thrombosis in children with cardiac disease.Journal of thrombosis and haemostasis : JTH · 2023Article
- What did we learn (and did not learn) from the pediatric direct oral anticoagulant trials, and how might we better design pediatric anticoagulant trials in the future?Research and practice in thrombosis and haemostasis · 2023Article
Corrections and comments
- Commented on by
- Erratum issued
Authors and funding
19 authors at 14 institutions in 9 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
This open-label, single-arm, prospective cohort trial is the first phase 3 safety study to describe outcomes in children treated with dabigatran etexilate for secondary venous thromboembolism (VTE) prevention. Eligible children aged 12 to <18 years (age stratum 1), 2 to <12 years (stratum 2), and >3 months to <2 years (stratum 3) had an objectively confirmed diagnosis of VTE treated with standard of care (SOC) for ≥3 months, or had completed dabigatran or SOC treatment in the DIVERSITY trial (NCT01895777) and had an unresolved clinical thrombosis risk factor requiring further anticoagulation. Children received dabigatran for up to 12 months, or less if the identified VTE clinical risk factor resolved. Primary end points included VTE recurrence, bleeding events, and mortality at 6 and 12 months. Overall, 203 children received dabigatran, with median exposure being 36.3 weeks (range, 0-57 weeks); 171 of 203 (84.2%) and 32 of 203 (15.8%) took capsules and pellets, respectively. Overall, 2 of 203 children (1.0%) experienced on-treatment VTE recurrence, and 3 of 203 (1.5%) experienced major bleeding events, with 2 (1.0%) reporting clinically relevant nonmajor bleeding events, and 37 (18.2%) minor bleeding events. There were no on-treatment deaths. On-treatment postthrombotic syndrome was reported for 2 of 162 children (1.2%) who had deep vein thrombosis or central-line thrombosis as their most recent VTE. Pharmacokinetic/pharmacodynamic relationships of dabigatran were similar to those in adult VTE patients. In summary, dabigatran showed a favorable safety profile for secondary VTE prevention in children aged from >3 months to <18 years with persistent VTE risk factor(s). This trial was registered at www.clinicaltrials.gov as #NCT02197416.
Indexed as
Identifiers
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.