Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2022 Aug;69(8):e29764.
doi: 10.1002/pbc.29764. Epub 2022 Jun 9.

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  1 , Ildar Nurmeev  2 , Pavel Svirin  3 , Kevin D Wolter  4 , Jean Li Yan  5 , Darshana Jani  4 , Neil A Goldenberg  6   7 , Nancy Sherman  4
Affiliations
Clinical Trial

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. Pediatr Blood Cancer. 2022 Aug.

Abstract

Data from registrational trials of pediatric venous thromboembolism (VTE) treatment are sparse, especially among cancer patients. We conducted a prospective, multicenter, open-label trial (NCT00952380) on dose-finding, safety, and efficacy (measured by 90-day risks of clinically relevant bleeding [CRB] and symptomatic recurrent VTE [srVTE]) of twice-daily subcutaneous dalteparin for acute VTE treatment in patients ≤18 years old. Among 38 patients (cancer, n = 26; noncancer, n = 12), median dalteparin dose requirements per kilogram varied with age but not cancer status. Risks of CRB and srVTE were <4% in cancer and noncancer subgroups. Dalteparin is an important FDA-approved treatment for pediatric VTE, particularly with cancer.

Keywords: dalteparin; malignancy; pediatric; thromboembolism; thrombosis.

PubMed Disclaimer

References

REFERENCES

    1. Heit JA, Silverstein MD, Mohr DN, Petterson TM, O'Fallon WM. Risk factors for deep vein thrombosis and pulmonary embolism: a population-based case-control study. Arch Intern Med. 2000;160:809-815.
    1. Otten HM, Prins MH, Smorenburg SM, Hutten BA. Risk assessment and prophylaxis of venous thromboembolism in non-surgical patients: cancer as a risk factor. Haemostasis. 2000;30(2):72-76, discussion 63.
    1. Palareti G, Legnani C, Lee A, et al. A comparison of the safety and efficacy of oral anticoagulation for the treatment of venous thromboembolic disease in patients with or without malignancy. Thromb Haemost. 2000;84:805-810.
    1. Prandoni P. Cancer and thromboembolic disease: how important is the risk of thrombosis? Cancer Treat Rev. 2002;28:133-136.
    1. Monagle P, Cuello CA, Augustine C, et al. American Society of Hematology 2018 Guidelines for management of venous thromboembolism: treatment of pediatric venous thromboembolism. Blood Adv. 2018;2:3292-3316.

Publication types

Associated data