THROMBOTECT – a randomized study comparing low molecular weight heparin, antithrombin and unfractionated heparin for thromboprophylaxis during induction therapy of acute lymphoblastic leukemia in children and adolescents

Autor: Greiner, Jeanette, Schrappe, Martin, Lassay, Elisabeth, Vorwerk, Peter, Lauten, Melchior, Sauerbrey, Axel, Rischewski, Johannes, Beilken, Andreas, Henze, Günter, Korte, Wolfgang, Möricke, Anja, THROMBOTECT Study Investigators†, Claviez, Alexander, Zimmermann, Martin, Niemeyer, Charlotte, Kolb, Reinhard, Eberl, Wolfgang, Berthold, Frank, Bergsträsser, Eva, Gnekow, Astrid
Přispěvatelé: University of Zurich, Greiner, Jeanette
Jazyk: angličtina
Rok vydání: 2019
Předmět:
Zdroj: Haematologica
Haematologica : journal of the European Hematology Association 104(4), 756-765 (2019). doi:10.3324/haematol.2018.194175
ISSN: 1592-8721
0390-6078
DOI: 10.3324/haematol.2018.194175
Popis: Thromboembolism is a serious complication of induction therapy for childhood acute lymphoblastic leukemia. We prospectively compared the efficacy and safety of antithrombotic interventions in the consecutive leukemia trials ALL-BFM 2000 and AIEOP-BFM ALL 2009. Patients with newly diagnosed acute lymphoblastic leukemia (n=949, age 1 to 18 years) were randomized to receive low-dose unfractionated heparin, prophylactic low molecular weight heparin (enoxaparin) or activity-adapted antithrombin throughout induction therapy. The primary objective of the study was to determine whether enoxaparin or antithrombin reduces the incidence of thromboembolism as compared to unfractionated heparin. The principal safety outcome was hemorrhage; leukemia outcome was a secondary endpoint. Thromboembolism occurred in 42 patients (4.4%). Patients assigned to unfractionated heparin had a higher risk of thromboembolism (8.0%) compared with those randomized to enoxaparin (3.5%; P=0.011) or antithrombin (1.9%; P
Databáze: OpenAIRE