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

Article Medicine, General & Internal

Effect of Anticoagulant Therapy for 6 Weeks vs 3 Months on Recurrence and Bleeding Events in Patients Younger Than 21 Years of Age With Provoked Venous Thromboembolism The Kids-DOTT Randomized Clinical Trial

Neil A. Goldenberg et al.

Summary: Among patients younger than 21 years of age with provoked venous thromboembolism, 6-week anticoagulant therapy was noninferior to 3-month therapy in terms of recurrent venous thromboembolism risk and bleeding risk.

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION (2022)

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Article Pediatrics

The Continued Rise of Venous Thromboembolism Across US Children's Hospitals

Sarah H. O'Brien et al.

Summary: This study evaluated the rate of pediatric venous thromboembolism (VTE) from 2008 to 2019 and found a significant increase in VTE cases during this period. These findings highlight the need for more effective VTE prevention strategies.

PEDIATRICS (2022)

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Article Hematology

Recommendations for standardized definitions, clinical assessment, and future research in pediatric clinically unsuspected venous thromboembolism: Communication from the ISTH SSC subcommittee on pediatric and neonatal thrombosis and hemostasis

Marisol Betensky et al.

Summary: Clinically unsuspected VTE in children has limited understanding of its clinical significance due to lack of data. Further research is urgently needed to inform optimal management. This article provides guidance recommendations for standardization of definitions and identifies future research needs.

JOURNAL OF THROMBOSIS AND HAEMOSTASIS (2022)

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Article Pediatrics

Enoxaparin Thromboprophylaxis in Children Hospitalized for COVID-19: A Phase 2 Trial

Anthony A. Sochet et al.

Summary: Among children hospitalized for COVID-19, thromboprophylaxis with twice-daily enoxaparin appears safe and warrants further investigation to assess efficacy.

PEDIATRICS (2022)

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Article Hematology

Incidence and impact of anticoagulation-associated abnormal menstrual bleeding in women after venous thromboembolism

C. M. M. de Jong et al.

Summary: Preliminary data and clinical experience suggest an increased risk of abnormal uterine bleeding (AUB) in women of reproductive age treated with anticoagulants, but there is a lack of solid data. In a study involving 98 women diagnosed with acute venous thromboembolism (VTE), 2 out of 3 women experienced AUB during anticoagulation treatment, with a significant negative impact on their quality of life (QoL).

BLOOD (2022)

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Article Oncology

A phase 2 pharmacodynamic dose-finding, safety, and efficacy study of dalteparin for pediatric venous thromboembolism treatment in children with and without cancer

Lisa R. Hartman et al.

Summary: This study found that there is a lack of data from registrational trials on pediatric venous thromboembolism (VTE) treatment, especially among cancer patients. Through a prospective trial, the dose-finding, safety, and efficacy of twice-daily subcutaneous dalteparin for acute VTE treatment in children were evaluated. The results demonstrate that dalteparin is an important FDA-approved treatment for pediatric VTE, particularly in cancer patients.

PEDIATRIC BLOOD & CANCER (2022)

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Article Cardiac & Cardiovascular Systems

Edoxaban for Thromboembolism Prevention in Pediatric Patients With Cardiac Disease

Michael A. Portman et al.

Summary: This study aimed to evaluate the safety and efficacy of edoxaban in children. The results showed that edoxaban is a potential alternative for thromboprophylaxis in children with cardiac disease, with low rates of bleeding and thrombotic events.

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY (2022)

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Article Critical Care Medicine

Efficacy of Early Prophylaxis Against Catheter-Associated Thrombosis in Critically Ill Children: A Bayesian Phase 2b Randomized Clinical Trial*

E. Vincent S. Faustino et al.

Summary: The study provides evidence on the efficacy and safety of early prophylaxis for central venous catheter-associated deep venous thrombosis in critically ill children. However, issues during the trial led to early termination, highlighting the need for further validation in a pivotal randomized clinical trial.

CRITICAL CARE MEDICINE (2021)

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Article Hematology

Dabigatran etexilate for the treatment of acute venous thromboembolism in children (DIVERSITY): a randomised, controlled, open-label, phase 2b/3, non-inferiority trial

Jacqueline Halton et al.

Summary: The study found that an age-adjusted and weight-adjusted dosing algorithm for dabigatran was effective in children with venous thromboembolism, showing similar pharmacokinetic-pharmacodynamic relationships to those seen in adults. In terms of efficacy, dabigatran was non-inferior to standard of care, indicating it may be a suitable alternative treatment option.

LANCET HAEMATOLOGY (2021)

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Review Hematology

Menstruation, anticoagulation, and contraception: VTE and uterine bleeding

Bethany Samuelson Bannow et al.

Summary: Abnormal or excessive menstrual bleeding affects a significant percentage of reproductive-aged women, with even higher rates seen in those on direct oral anticoagulants (DOACs). Management options include progestin-only therapies, combined hormonal contraceptives, and procedural therapies for women who have completed childbearing. Monitoring for iron deficiency and anemia is crucial in these cases, along with discussing management strategies early on.

RESEARCH AND PRACTICE IN THROMBOSIS AND HAEMOSTASIS (2021)

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Article Hematology