TropicALL study

Suspended

Conditions: TropicALL, ALL, Acute Lymphoblastic Leukemia, Thromboprophylaxis, Children Low-molecur-weight heparin, venous thrombosis.TropicALL, ALL, Acute Lymfoblastische Leukemie, tromboprofylaxe, kinderen, laag-moleculair-gewicht heparine (LMWH), veneuze trombose

Registration Number: NL-OMON23171

Lead Sponsor: Dutch Childhood Oncology Group (DCOG)Stichting Kinderoncologie Nederland (SKION)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Suspended

Sex: Not specified

Target Recruitment: 354

Inclusion Criteria

All patients between 1 and 19 years of age with primary ALL, who are eligible for and treated within the DCOG ALL-11 or 12 study protocol.

Exclusion Criteria

a.Patients who are already being treated with anticoagulation upon screening (for other indications)

b.Patients with a heparin allergy (or for one of its components), a recent history (within 6 months) of heparin-induced thrombocytopenia (HIT) or any other contraindication listed in the local labeling of LMWH

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of symptomatic objectified VTE during childhood ALL treatment in the intervention and standard arm.

Secondary Outcome Measures

Name	Time	Method
1.Incidence of the composite of major bleeding or clinically relevant non-major bleeding in the intervention and standard arm;<br /><br>2.Incidence of composite of asymptomatic and symptomatic objectified VTE during childhood ALL treatment in the intervention and standard arm.<br /> <br>3.ALL treatment outcomes by assessment of complete remission and (overall or disease-free) survival rates in the intervention and standard arm;<br /><br>4.Identification of clinical risk factors and hematological biomarkers in consecutively included patients with and without VTE; to increase insight in the pathogenesis of coagulation disorders during ALL treatment, and to establish a risk model for VTE<br>