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- Title
TropicALL study: Thromboprophylaxis in Children treated for Acute Lymphoblastic Leukemia with Low-molecular-weight heparin: a multicenter randomized controlled trial.
- Authors
Klaassen, Irene L. M.; Lauw, Mandy N.; van de Wetering, Marianne D.; Biemond, Bart J.; Middeldorp, Saskia; Abbink, Floor C. H.; Bierings, Marc; te Loo, D. Maroeska M. W.; Pieters, Rob; van der Sluis, Inge M.; Tissing, Wim J. E.; Zwaan, C. Michel; van Ommen, C. Heleen; Michel Zwaan, C; Heleen van Ommen, C
- Abstract
<bold>Background: </bold>Venous thromboembolism (VTE) is a common and severe complication during treatment of acute lymphoblastic leukemia (ALL). An important cause is the intensive use of asparaginase. Prospective cohort studies in which prophylactic low-molecular-weight heparin (LMWH) was used to prevent VTE showed lower VTE risk than in historic control cohorts, with a negligible bleeding risk. However, the efficacy of thromboprophylaxis with LMWH during ALL treatment has never been investigated in a randomized design. Here, we present the protocol of a randomized controlled trial in which the efficacy and safety of thromboprophylaxis with high prophylactic dose LMWH versus no thromboprophylaxis will be assessed in children treated for primary ALL with asparaginase.<bold>Methods/design: </bold>Thromboprophylaxis in Children treated for Acute Lymphoblastic Leukemia with Low-molecular-weight heparin (TropicALL) is a multicenter, randomized controlled open-label trial conducted in the Netherlands. Patients between 1 and 19 years of age with primary ALL, who are treated within the Dutch Childhood Oncology Group (DCOG) ALL-11 or 12 study will be randomized to thromboprophylaxis with LMWH once daily, (dose of 85 IU/kg (intervention arm A)), or to no thromboprophylaxis (arm B, standard of care) during asparaginase courses of ALL treatment. Primary efficacy endpoint is symptomatic objectified VTE during ALL treatment; secondary efficacy endpoints are overall survival and the composite of symptomatic and asymptomatic objectified VTE. Primary safety endpoints are major bleeding, clinically relevant non-major bleeding and minor bleeding. A total of 324 patients will be included to obtain a relative risk reduction of 75% with a power of 80%, using a two-sided test with significance level α = 0.05.<bold>Discussion: </bold>This trial will be the first to assess efficacy and safety of thromboprophylaxis with LMWH during asparaginase treatment for ALL in children in a randomized design.<bold>Trail Registration: </bold>Nederlands Trial Register NTR4707 . Registered 30 July 2014.
- Subjects
THROMBOEMBOLISM in children; RANDOMIZED controlled trials; ANTICOAGULANTS; MOLECULAR weights; ASPARAGINASE; HEPARIN; THROMBOEMBOLISM prevention; ENOXAPARIN; ANTINEOPLASTIC agents; COMPARATIVE studies; DRUG administration; LONGITUDINAL method; LYMPHOBLASTIC leukemia; RESEARCH methodology; MEDICAL cooperation; MEDICAL protocols; RESEARCH; THROMBOEMBOLISM; VEINS; EVALUATION research; TREATMENT effectiveness; THERAPEUTICS
- Publication
BMC Pediatrics, 2017, Vol 17, p1
- ISSN
1471-2431
- Publication type
journal article
- DOI
10.1186/s12887-017-0877-x